Elastic Stable Intramedullary Nailing of Forearm Shaft Fractures by Titanium Compared With Biodegradable Nails: Results of a Prospective Randomized Trial in Children With at Least Two Years of Follow-up
Phase: NA
Conditions: Forearm Fracture
Sponsor: Jaakko Sinikumpu

Clinical Investigation Plan
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
Clinical Investigation Plan
BIOABSORBABLE INTRAMEDULLARY NAIL FIXATION OF 
FOREARM FRACTURES IN CHILDREN 
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Clinical Investigation Plan
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TABLE OF CONTENTS
1
Abbreviations...............................................................................................................5
2
Identification.................................................................................................................5
3
Contact Information......................................................................................................6
4
Synopsis......................................................................................................................7
5
Identification of the Investigational Device...................................................................9
6
Identification of the Control Device...............................................................................9
7
Preliminary Investigations and Justification of the Study..............................................9
7.1
Literature Review................................................................................................10
7.2
Preclinical Testing...............................................................................................12
7.3
Risk Analysis and Risk Assessment....................................................................12
8
Objectives..................................................................................................................13
8.1
Primary Objectives..............................................................................................13
8.2
Secondary Objectives.........................................................................................13
9
Design of the Clinical Investigation............................................................................14
9.1
Type and Design of The Study............................................................................14
9.2
Selection of the Study Population and Enrollment...............................................14
9.3
Prior Treatment...................................................................................................16
9.4
Concomitant Treatment.......................................................................................17
9.5
Assessments and Procedures.............................................................................17
9.6
Evaluation of Variables........................................................................................23
10
Statistics.....................................................................................................................25
10.1
Sample Size Considerations...............................................................................25
10.2
Statistical Hypothesis..........................................................................................26
10.3
Statistical Methods..............................................................................................26
11
Adverse Events..........................................................................................................27
12
Quality Management..................................................................................................27
12.1
Monitoring Arrangements....................................................................................27
12.2
Data Management...............................................................................................28
12.3
Quality Assurance...............................................................................................28
13
Discontinuation and Withdrawal of Subjects..............................................................28
14
Termination of the Study............................................................................................28
15
CIP Amendments and Deviations..............................................................................29
16
Publication Policy.......................................................................................................29
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Clinical Investigation Plan
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
17
Subject Injury.............................................................................................................29
18
Report Forms.............................................................................................................29
19
References.................................................................................................................30
20
Appendixes................................................................................................................31
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Clinical Investigation Plan
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Change History
Version
Date
Description
1
11/2009
Initial version
2
11.11.2009
3
19.2.2010
Adding of signatures and corrections of version and dates
4
17.3.2011

Updating of investigation sites and team 

Adding of two pilot operations per investigation site

Updates of inclusion criteria concerning the subjects’ age and exclusion 
criteria concerning delay time of operation 

Adding of 2 mm bioabsorbable IM nail to the device list for the young subject 
with narrow bone cavity

Additional instructions to the surgical procedure

Schedule of MRI imaging 
5
5.2.2018

updated study group and coordinating researcher

power analysis re-performed and N of study and control cases changed

objectives were focused

typographical errors were corrected
_________________________________
_________________________________
Juhani Merikanto, M.D., PhD. Assoc. Prof.
Jaakko Sinikumpu, MD, PhD. Assoc. Prof.
Principal Clinical Investigator 
Coordinating Investigator
   
_________________________________
_________________________________
Minna Veiranto, Director, Clinical Affairs
Mari Ruotsalainen, Q&RA Manager
Bioretec Ltd
Bioretec Ltd 
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Clinical Investigation Plan
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
Abbreviations
AE
Adverse Event
AO
Arbeitsgemeinschaft für Osteosynthesefragen
AP
Anterior-Posterior –direction
BMI
Body Mass Index
CIP
Clinical Investigation Plan
CRF
Case Report Form
Galeazzi fracture 
middle to distal third radius fracture, with intact ulna, and 
disruption of the distal radioulnar joint
IM
Intramedullary Nail
Monteggia fracture
proximal ulna fracture with associated dislocation of the 
radial head
MRI
Magnetic Resonance Imaging
ORIF
Open Reduction and Internal Fixation
PLLA
Poly-L-lactide
ROM
Range of Motion
RUS
Region Under Study
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SOP
Standard Operation Procedure
SR
Self-reinforcing, an orientation method applied to increase 
the  strength  of  the  bioabsorbbale  implant  materials,  e.g. 
polylactide => SR-PLLA
TEN
Titanium Elastic Nail
VAS
Visual Analogue Scale
Identification
Clinical  Investigation  Plan  Title:  Bioabsorbable  Intramedullary  Nail  Fixation  of  Forearm 
Fractures in Children
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Clinical Investigation Plan
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Contact Information
Sponsor:
Bioretec Ltd.
Hermiankatu 22, P.O. Box 135, FI-33721 Tampere, FINLAND
Minna Veiranto, Director, Clinical Affairs
minna.veiranto@bioretec.com, +358 40510 3681
Principal Clinical Investigator:
Juhani  Merikanto,  MD,  PhD,  Associate  Professor,  Paediatric  Surgeon  and 
Orthopedist
Coordinating Investigator:
Jaakko Sinikumpu, MD, PhD, Associate Professor of Paediatric Orthopaedics and 
Traumatology, Pediatric Surgeon and Orthopedist
Institutions, in which the clinical investigation will be conducted, and investigators:
Oulu University Hospital, Department of Children and Adolescents
P.O. Box 23, FIN-90029 OYS, Finland
o
Jaakko Sinikumpu, Associate Professor, MD, PhD, Paediatric Orthopedist and 
Surgeon
o
Willy Serlo, MD, Professor, MD, PhD, Chief Paediatric Orthopedist and Surgeon
o
Linda Korhonen, MB, PhD candidate
o
Tytti Pokka, MSc, Statistician
o
Marja Perhomaa, MD, Chief Paediatric Radiologist
Central Hospital of Päijät-Häme, Department of Surgery
Keskussairaalankatu 7, FIN-15850 Lahti, Finland
o
Antti Kyrö, MD, PhD, Orthopaedic Surgeon
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Clinical Investigation Plan
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Synopsis
Name of Sponsor: 
Bioretec Ltd.
Name of Medical Device: 
Bioabsorbable Intramedullary Nail
Title of Study: 
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
Investigators: 
o
Juhani Merikanto, MD, PhD, Associate Professor, Paediatric Surgeon
o
Antti Kyrö, MD, PhD, Orthopaedic Surgeon
o
Tytti Pokka, MSc, Statistician
o
Linda Korhonen, MB, PhD candidate
o
Marja Perhomaa, MD, Paediatric Radiologist
o
Willy Serlo, MD, Professor, MD, PhD, Paediatric Orthopedist and Surgeon
o
Jaakko Sinikumpu, Associate Professor, MD, PhD, Paediatric Orthopedist and 
Surgeon
Study Centres: 
-
Oulu University Hospital, Department of Children and Adolescents
-
Central Hospital of Päijät-Häme, Department of Surgery, Unit of Paediatric Surgery
Studied Period (weeks): 52 (follow up 2 years)
Date of First Enrolment: 2010
Date of Last Completed: 2018
Objectives: 
Primary objective: Clinical outcome of the fracture treatment is equal between patients treated 
by the new bioabsorbable medical device and by standard of care using a titanium alloy 
device. This will be assessed by functional and clinical outcome measuring range of motion of 
forearm, wrist and elbow and pain assessment at two-years’ follow-up. 
Secondary objective: The new medical device (bioabsorbable intramedullary nail) is at least 
as good as the routinely used device (elastic stable titanium alloy intramedullary nail) in 
forearm fracture treatment to achieve a level of reduction and stabilisation that is appropriate 
to the age of the child. This will be assessed by radiological outcome and determination of 
bony  union  formation  and  alignment  in  the  healing  forearm  fracture  using  radiographic 
methods; further, soft-tissue and bone-tissue reactions are to be evaluated by MRI.
Methodology: 
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Clinical Investigation Plan
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The fracture is fixed using the new medical device (bioabsorbable intramedullary nail) or the 
standard titanium intramedullary nail.
Number of Patients: At most 2 pilot operations / study centre + Planned 13 operations required 
for analysis; Total 35 patients to be enrolled, appreciating the potential drop-outs. 
Diagnosis and Main Criteria for Inclusion and Exclusion: 
Diagnosis: 
Children with an unstable midshaft (diaphyseal) forearm (radius and/or ulna) fracture.
Main inclusion and exclusion criteria: The subject and/or guardian has signed and dated the 
informed consent, the subject is 5 to 16 years of age, the subject has no previous fracture or 
infection of the study region, no metabolic bone disease, no systematic disease or medication 
affecting bone quality or resistance to infection.
Medical Test Device installation and identification: 
The device is surgically implanted. The batch of device is identified by test device name, 
packaging date and clinical investigation number A2228-CIP-1.
Duration of Treatment: 
The follow-up of the patients will be 104 weeks (2 years). The control device will be removed 
6 months after operation. The bioabsorbable device is expected to retain its mechanical 
functionality for at least 8 weeks, while the complete bioabsorption of the device in human 
body is expected to take place within approx. 2 years.
Criteria for Evaluation: 
Repeated examination  of functional, clinical and  radiographic outcome,  and  bone union 
formation  by  range  of  motion  measurement,  radiography (plain  radiographs).  Magnetic 
resonance imaging for a randomly selected subgroup of at least 10 patients treated by test 
device, general questionnaires.
Efficacy: 
The success of fixation will be determined by radiographic measurements in comparison 
between the immediate postoperative state and 6, 12 and 26 weeks after surgery.
Safety: 
Continuous evaluations of safety parameters and specific evaluations of adverse events and 
serious adverse events will take place at each postoperative study visit. The safety variables 
to  be  evaluated  include  adverse  events,  findings  from  physical  and  radiographic 
examinations, subjective reports of pain and functional outcome assessments.
Statistical Methods: 
The primary variable will be analysed using an analysis of variance model for repeated 
measurements. Treatment differences with 95% confidence intervals will be calculated from 
the model.
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Clinical Investigation Plan
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Identification of the Investigational Device
Investigational devices for intramedullary nail fixation  are manufactured by Bioretec Ltd. 
Devices are  intended for forearm fracture repair of  radial and/or ulnar shaft.  The main 
purpose of the device is to  achieve  a level of reduction and stabilisation of fracture that is 
appropriate  to  facilitate  the  uneventful bone  healing,  thus restoration  of  the  pre-trauma 
anatomical structure, taking into account the age of the child. In addition,  the need for the 
second operation to remove hardware will be obviated by the investigational devices.
Devices are made of bioabsorbable oriented high-strength poly(lactide-co-glycolide) (PLGA) 
85:15. The diameter of the IM nails is 2.0 mm, 2.7 mm or 3.2 mm. The nails are 400 mm long 
and in the tips of the nails there are x-ray positive markers. The high strength of IM nails is 
result  of  special  orientation  techniques  applied  in  the  manufacturing  of  the  products at 
Bioretec Ltd. The corresponding shorter product, ActivaPin™ is registered product, which has 
been on the EU and US markets already several years.
Prior training in the insertion techniques of bioabsorbable devices is recommended.  
Identification of the Control Device
Commonly used titanium elastic nail (TEN) manufactured by SynthesDePue Inc. is used as a 
control device in this study. According to routine clinical practices, the control device LOT 
number is documented into CRF.  The main purpose of the device is to  achieve  a level of 
reduction and stabilisation of fracture that is appropriate to facilitate the uneventful bone 
healing, thus restoration of the pre-trauma anatomical structure, taking into account the age of 
the child.  Prior training in the insertion techniques of TEN nails is recommended.
Preliminary Investigations and Justification of the Study
The purpose of this prospective, randomized clinical trial is to assess the efficacy and safety 
of a bioabsorbable device in fixation of forearm fracture patients. As the primary endpoint, the 
bioabsorbable intramedullary nail is expected to act as efficiently as the routinely used TEN 
nails in stabilization of forearm fractures in pediatric patients with unstable radius and/or ulna 
fractures.
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Literature Review
Closed reduction and plaster cast immobilization provides in most cases of children’s forearm 
fractures sufficient stability for an uneventful healing of the fracture and gives a satisfactory 
end result. [1-5] The satisfactory results are achieved due to rapid healing and remodelling of 
angulations in children.
However, in cases of 

unstable fractures (e.g. midshaft diaphyseal forearm fractures),

fractures with unacceptable alignment and fracture dislocations, 

open fractures, 

segmental fractures, 

proximal fractures that will not remodel as predictably and 

those with associated neurovascular compromise 
an operative treatment is often mandatory to avoid residual deformity with permanent loss of 
forearm rotation. [1, 3, 6-9] Remodeling will not correct rotational deformities of the distal third 
of the forearm; for that reason, rotational deformities must be often treated operatively. [2] In 
addition, in an older child ability for fracture remodeling and correction of deformity is not as 
effective  as  in  a  younger  child,  therefore  the  operative  treatment  of  displaced  forearm 
fractures is often recommended in children older than 10 years of age and in younger children 
when conservative treatment fails.
Effective operative alternatives of unstable fractures include open reduction and internal 
fixation (ORIF) with plates and screws or mini-open reduction and intramedullary (IM) nailing. 
[1, 8-10] The choice of fixation usually is a matter of surgeon preference.
Plate fixation allows anatomic reduction and early motion with most studies showing good 
outcomes  in  the  pediatric  population.  However,  plate  fixation  requires  a  large  surgical 
approach and smaller children may have bones that are too narrow to accommodate a plate. 
[8] In addition, incision for a plate fixation is greater than that required for IM nailing. In 
contrary to TEN nailing if plate fixation is applied the injured area of bone is exposed. This 
may also have a negative effect on the healing of the fracture by disturbing the haematoma 
and callus formation and increase complication possibilities, like infection. Plate removal is 
also associated with significant complications, such as nerve injury, and in addition, the 
removal of plate may be difficult due to scarring and bone growth over the plates. [9]
Flexible intramedullary nailing of pediatric forearm fractures has shown also excellent results. 
[2, 7, 9-12]  The advantages of closed reduction and IM nailing include a minimally invasive 
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Clinical Investigation Plan
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form of treatment of pediatric fractures and avoiding large incisions, shorter procedures, and 
ease of hardware removal, with a lower refracture rate compared with plates. [2, 10] Usually, 
TEN nails can be placed without disturbing the fracture site in some cases; however, in others 
the fracture is open, reduced, and fixated with the nail. Titanium elastic nails are a popular 
choice, but rush rods and Steinman pins/Kirschner wires also are used. [7, 10-13]
The inherent disadvantageous of these metallic devices are stress shielding phenomenon, 
pain and local irritation. [14, 15] Retained metallic implants provide an attractive and stable 
host  surface  for  intraoperatively  derived  bacteria  and  possess  the  risk  of  endogenous 
infection.  Release of metallic ions from these implants has been documented, though the 
long-term effects of these are not yet known. Because of these reasons in the use of metallic 
IM nails there is also need for a second operation to remove hardware after the bone has 
healed. The removing of IM nail is performed when the full healing has occurred, usually 4 - 6 
months after operation, but the nails are removed earlier if a bridging callous is present and 
the hardware is prominent or painful. Generally, the removal operation of metallic devices has 
significant economic implications, including the costs of the procedure as well as possible 
work  time  lost  by  the  parents  accompanying  the  removal  operation.  Especially  for  the 
pediatric patients and their parents the removal operation causes needless discomfort and 
concern. The removal operation also always possesses the risk of anesthesia complications 
and infection. The problems presented above have led to the development of bioabsorbable 
IM nails.
Bioabsorbable devices and IM nails  
During the last decades bioabsorbable implants made utilizing orientation techniques have 
gained  a  wide  acceptance  in  the  treatment  of  various  cancellous  bone  fractures  and 
osteotomies. Due to their complete biodegradation character the need for a second operation 
for removal of the device is overcome and long-term interference with children’s growing 
skeleton is avoided. These implants also offer the advantages of gradual load transfer to the 
healing tissue, reduced risk of peri-implant osteoporosis and infection. An important aspect is 
that these implants do not interfere with clinical imaging after surgical implantation. [15]
In paediatric orthopaedics Bostman et al. showed that self-reinforced absorbable rods were 
suitable for fixation of physeal fractures in children. [16] In 1991, Hope et al. had compared 
the self-reinforced absorbable rods with metallic fixation of elbow fractures in children. [17] 
Partio  et  al  found  SR-PLLA  screws  firm  enough  for  fixation  of  subtalar  extra-articular 
arthrodesis in children. [18] Bioabsorbable fixation technique for pediatric olecranon fractures 
has been described, with the advantage of avoiding reoperation to remove hardware. [19] 
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Clinical Investigation Plan
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Favorable results on treatment of forearm fractures by bioabsorbable intramedullary nails was 
gained already in the 1990. [20-22] In that study the poly-L-lactide (PLLA) IM-rods seemed to 
be a viable option in the treatment of children’s fore-arm fractures, based on 3,5 years follow-
up carried out in this study.
Bioretec’s  ActivaPinTM products  have  gained  excellent  clinical  outcome  in  the  different 
indications of orthopedics and trauma surgery. The modified (lengthened) bioabsorbable 
devices for fixation of children’s unstable forearm fractures are manufactured by Bioretec Ltd 
based on ActivaPin™ technology. Devices are intended for repair of children’s unstable 
forearm (radius and/or ulna) fractures. In addition to extended length an X-ray marker has 
been added to the tip of the implant to facilitate the similar insertion technique applied for TEN 
nails,  which  utilizes  fluoroscopy  to  monitor  the  position  of  the  tip  of  the  implant  intra-
operatively. The main purpose of the device is to stabilize diaphyseal forearm fractures of 
children in the alignment of the repositioned state for at least 6 weeks in the presence of 
appropriate immobilization and to obviate the need for second operation to remove the 
hardware. The operation technique of these bioabsorbable IM nails is very similar to that of 
metallic IM nails.
Preclinical Testing
Preclinical testing is not applied, as the materials have known toxicological profiles and well-
established  track  record  of  safe  clinical  use  in  other  application  areas  comparable  to 
intramedullary nail fixation of forearm fractures. The manufacturing methods of bioabsorbable 
IM nails are well established in manufacturing of similar implants to different application 
areas.
Risk Analysis and Risk Assessment
The risk management of this clinical investigation has been made according to current risk 
management standard for medical devices (ISO 14971) and according to risk assessment the 
residual risk is acceptable. Based on risk assessment the risk is negligible that the 85/15 
PLGA implants would cause any bioincompatibility reactions in this indication. The residual 
risk of each hazard was estimated based on the probability and severity of occurrence. 
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Clinical Investigation Plan
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Objectives
Primary Objectives 
The primary objective of the study is to evaluate the feasibility and efficacy of the new medical 
device  in treatment of paediatric patients with forearm fractures. The key variables in this 
assessment are the evaluation of the functional and clinical outcome by measuring range of 
motion  in  forearm,  wrist  and  elbow  (e.g.  measuring  supination/protonation  and  flexion-
extension  movements),  and  subjective  pain  assessment  during  recovery.  The  primary 
objective will be met if these outcomes in the treatment group are at least comparable to 
those of the patients treated with standard of care (TEN nail), interpreted by using the Price’s 
classification system (<15 degrees of change in motion range is excellent clinical outcomes), 
and Flynn’s criteria for upper extremity assessment (<10 degress of change in motion range 
justifies satisfactory outcomes). The potential difference less than 10 degrees are to be 
determined not clinically significant. The raw results of clinical measurements and statistical 
significance of each finding are to be reported.
Secondary Objectives
The secondary objectives of the study are to evaluate the  radiographic outcome of the 
forearm fracture treatment in patients treated using the study device. The key variables in 
assessment of these objectives are: 

fracture reduction and angulation,

formation of bridging callus and consolidation (union, delayed union, non-union and 
malunion)
The method in assessment of key variables is plain radiographic evaluation. The secondary 
objective will be met if these outcomes in the treatment group are at least comparable to 
those of the patients treated with standard of care (TEN nail). According to the previous 
literature, angular deformity of <10 degrees in radius and/or ulna is to be determined not 
clinically significant [27-29]. 
Soft-tissue  reaction  against  the  biodegradable  implant  are  to  be  studied  by  Magnetic 
Resonance Imaging (MRI) for a randomly selected sub-group of at least 10 patients.
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Design of the Clinical Investigation
Type and Design of The Study
This  is  a  randomized  parallel-group  two-centre study  on  the  use  of  bioabsorbable 
intramedullary nail device for fixation of the radial and ulnar shaft fractures in children. All 
patients will receive the standard of care for other injuries caused by the trauma.
35 subjects will be enrolled at the University Hospital of Oulu and Central Hospital of 
Päijät-Häme to appreciate the potential drop-outs. The minimum number of patients in  
both groups (study implant vs. titanium implant) is 13. To minimize any selection bias, 
the patients will be sequentially randomized into these groups.
The study cannot be executed in a blinded fashion, because the orthopaedic surgeon and the 
operating room staff will inevitably be aware of the type of the implanted device. The patient 
must be also informed if the signed implant needs removal: the titanium alloy devices will be 
removed at 6 months, while the absorbable device will not require removal surgery. 
Selection of the Study Population and Enrollment
The study begins with the signing and dating of the informed consent. All subjects and/or 
guardian must provide inform consent. During the consent procedure, the person obtaining 
consent must inform the subject of all elements of informed consent. Adequate time must be 
allowed for the subject to ask questions and make a voluntary decision. No protocol-specific 
procedures, including screening procedures, are performed until the subject has signed and 
dated the independent ethics committee approved informed consent form. Subjects must also 
meet the inclusion and exclusion criteria to be enrolled in the study. The participation in this 
clinical investigation is voluntary and the subject may interrupt the participation at any time, 
which is to be clearly informed.
1.1.1
Inclusion Criteria

Subject’s signed and dated informed consent

Patients between 5 and 16 years of age, but diameter of bone marrow canal at least 2 
mm

Alert person oriented to place and time

Acute, radius and/or ulna shaft fractures (antebrachium diaphysis)
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Clinical Investigation Plan
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o
Satisfactory alignment must be in prior considered to be achieved by closed 
or open reduction
1.1.2
Exclusion Criteria

Previous fracture or infection of the injured forearm bones (i.e. the radius and/or ulna)

Severe overweight; body mass index (BMI) over 30

Fracture older than 5 7 days

Distal fracture patterns in the transition zone of the distal metaphysis to diaphysis of 
the radius, classified as metaphyseal or metadiaphyseal fractures.

Monteggia fracture dislocation

Galeazzi fracture dislocation 

Open fracture other than a slight inside-out –wound and significant associated soft-
tissue injury, particularly in connection with intra-articular fractures and polytrauma

Pathological fractures with juvenile bone cysts

Documented active infection at any anatomical site

A known metabolic skeletal disease (such as osteoporosis or osteomalacia) or 
medication affecting the bone structure (cortisone treatment)

Any underlying systemic illness (such as unbalanced diabetes mellitus or rheumatic 
disease) or condition which are known to affect resistance to infection 

Any other condition that in the judgment of the investigator would prohibit the subject 
from participating in the study or may hinder the collection of data and interpretation 
of the results. 

The patient has participated in any other device or drug related clinical trial within the 
previous month

Patients certainly requiring open reduction to achieve satisfactory alignment
1.1.3
Number of Subjects
35 subjects will be treated under this protocol. At least 13 subjects are enrolled and treated in  
both groups to assess the safety and efficacy of the new implant. As there may occur  
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withdrawals  there  are  more  subjects  to  be  treated  than  is  required  by  samples  size  
calculation.
Each study centre will operate at most two forearm fracture patients using the bioabsorbable 
intramedullary nails before the actual study subjects. This way the investigators will familiarize 
sufficiently with the surgical technique and use of bioabsorbable intramedullary nails in order 
that the outcome of the bioabsorbable intramedullary nails and titanium elastic nails would be 
comparable. These patients must be selected according to the chapter 9.2, and they and/or 
guardian must provide inform consent. The operations and the follow-up of their recovering 
will be performed according this clinical investigation plan; however, according to a decision 
of the study group, these patients will not be included in the evaluation of the outcome and 
key variables.
1.1.4
Screen Failures
Subjects who sign an informed consent form and fail to meet the inclusion and/or exclusion 
criteria are defined as screen failures. For all screen failures, the investigator is to maintain a 
screening log that documents the screening number, subject initials, and the reason for 
screen failure. 
Prior Treatment
Prior to treatment the subjects will sign an informed consent form, stating that they are 
acquainted with the surgical procedure and study, and that they consent to participate in the 
study.
Reasonable efforts will be made to determine all relevant treatment received by the subject 
within 4 weeks prior to administration of the randomized treatment assignment. All relevant 
information will be recorded on the subject’s CRF: 

Patient demographics

Aetiology (e.g. bicycle accident, fall, sports) and injury mechanism

Fracture type
o
proximal, middle, or distal shaft according to anatomic location
o
angular and rotational deformities, and displacement
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Clinical Investigation Plan
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Concomitant Treatment
1.1.5
Permitted Treatment
The following concomitant medications and therapies will be permitted:

The treatment normally clinically applied when fixation is carried out using TEN nails 
is acceptable also in this study. In other words, the patients will receive all treatments 
needed for their injuries as the standard of care defines. The concomitant 
medications, therapies and treatments, which may reasonably be expected to 
interfere with the results of forearm fracture healing, will be reported in CRF.

Due to the nature of the study, it is acceptable to leave out the detailed dosage 
information of concomitant medication in the CRF. This means that “N.A.” (= not 
applicable/available) can be documented into the Concomitant Medication CRF into 
the columns of “Single dose and unit” and “Frequency”.
1.1.6
Prohibited Treatment

Subjects will not be permitted to use other investigational treatments during the 12 
months following administration of the randomized treatment assignment.

To avoid potential interactions that may interfere with fracture healing, the following 
concomitant medications and therapies are prohibited:
o
Osteoporosis medications (such as bisphosphonates and SERMs)

Hormone replacement and calcium-D-vitamin preparations are, 
however, permitted

Additional procedures for the region of the study which may interfere fracture healing 
(such as ultrasound treatment)
Assessments and Procedures 
1.1.7
Visit Schedule
For  each  subject,  the  study  consists  of  assessments  preoperatively,  immediately  after 
operation and the follow up visits postoperatively. The recommend time window of scheduled 
visits is 7 days. The clinical assessments and procedures performed at each visit are shown 
in Table 2. 
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During these visits will be investigated: function of both arms, radiological fracture healing, 
well-being and incidence of complications.
Table 2     Assessment and procedures at each visit
Assessment
Operation
4 week 
12 
weeks 
26 
weeks
52 
weeks 
104 
weeks
Pre-
operative
Post-
operative
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Call 6
Visit 7
Informed 
consent, 
inclusion and 
exclusion 
criteria
X
Demographics, 
medical history
X
Injuries and 
comorbidities
X
Randomization
X
Fracture 
reduction and 
fixation
X
Cast removal
X
TEN nail 
removal
X
Primary 
performance 
variable
Operation
4 week 
12 
weeks 
26 
weeks
52 
weeks 
104 
weeks
Pre-
operative
Post-
operative
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Call 6
Visit 7
Functional and 
clinical outcome 
evaluated by 
measuring rate 
of motion
X
X
X
X
Pain 
assessment
X
X
X
X
X
X
Subjective 
X
X
X
X
X
X
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result
Secondary 
variables 
Operation
4 week 
12 
weeks 
26 
weeks
52 
weeks 
104 
weeks
Pre-
operative
Post-
operative
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Call 6
Visit 7
Radiographic 
outcome and 
bone union 
formation 
evaluated by  
plain 
radiographs
X
X
X
X
X
X
Radiographic 
outcome and 
bone union 
formation 
evaluated by  
MRI imaging
X*
X*
X*
X*
Safety and 
tolerability 
variables
Operation
4 week 
12 
weeks 
26 
weeks
52 
weeks 
104 
weeks
Pre-
operative
Post-
operative
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Call 6
Visit 7
Adverse events
X
X
X
X
X
X
X
Concomitant 
medications
X
X
X
X
X
X
X
Conclusion of 
participation
X
* Radiographic outcome and bone union formation of 5-10 subjects will be evaluated by MRI 
imaging immediately after operation and three follow up visits
1.1.8
Surgical Procedure
The surgery will be performed by a paediatric surgeon, paediatric orthopaedic surgeon, 
orthopaedic  surgeon  or  by  a  resident  specializing  in  paediatric  orthopaedic  surgery.  In 
surgery, standard AO techniques will be applied. The surgery will have the following steps:
1.
Patients  are  placed  supine  on  a  standard  operating  room  table  and  general 
anesthesia is induced.
2.
The arm is prepared and draped in the usual sterile fashion. A tourniquet is used as 
necessary, according to the decision of the operating surgeon.
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3.
Following necessary irrigation of any open wounds, attention is then turned to IM 
nailing. 
a.
The more angulated/displaced bone is addressed first and stabilized. 
b.
If the second bone reduces anatomically with stabilization of the first bone, it 
is treated closed 
4.
Either a bone awl or a 4.5-mm drill bit is used to make an entry portal into the cortical 
bone
a.
To treat the radius, a 1-cm longitudinal incision is made over the dorsolateral 
metaphyseal surface just proximal to distal physis (C-arm image is used to 
aid in the placement of the incision), with care taken to avoid the dorsal 
branch of the superficial radial nerve. 
b.
All ulnae are treated by inserting the IM device from proximal to distal, 
avoiding the proximal physis using the above technique. 
5.
If an acceptable reduction cannot be achieved closed, then a mini open incision 
directly over the fracture site is made and any interposing tissue removed. 
6.
Bone marrow canal is reamed using the metallic intramedullary nail (Ø 2.0, 2.5, 3.0 or 
3.5 mm). 
a.
The reaming metallic intramedullary nails are left to bone marrow canals until 
it is time to insert bioabsorbable IM nail. The metallic intramedullary nails are 
removed and replaced by bioabsorbable IM nail one by one.
b.
The diameter of the metallic intramedullary nail and bioabsorbable IM nail will 
be  determined  according  to  the  estimation  about  the  diameter  of  bone 
marrow canal by radiograph. The largest possible implant is to be applied.
7.
After reaming of canal, the bioabsorbable IM nail (Ø 2.0, 2.7 or 3.2 mm) is inserted to 
canal using nail inserter.
a.
In the installation of bioabsorbable IM nail the “slide hammer” of the insertion 
tool has to be used without rotational motion, because the nail may expand 
because of heat due to rotational motion and friction.
b.
Use of drill sleeve is recommended during installation of the nail.
8.
Following insertion of the bioabsorbable IM nail, it is cut using oscillating saw or hot 
wire. 
9.
The wounds are closed in layers using standard principles.
10. The immobilization of forearm is performed by dorsal plaster cast with volar support 
for 4 - 6 weeks with the elbow flexed to 90 degrees. After that, additional appropriate 
immobilization should be considered by the treating physician.
11. Sport activities should be limited for 3-6 months.
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The operation technique is much the same as that with metallic IM nailing fixation. The 
differences of techniques are that  

the separate reaming of bone marrow is not performed with metallic IM nail fixation

the end of the TEN nail is left out about 6 - 7 mm from the cortex for removing of the 
nail
o
Wound is closed in layers over the end of the TEN nail

the TEN nail is removed in second operation after 6 months in general anesthesia.  
1.1.9
Functional and Clinical Outcome Measurements
Healing of the injury will be clinically monitored using repeated functional measurements, pain 
assessments and by means of standardized questionnaires. The follow-up will be performed 
according to table 2. The functional examinations will include the supination and pronation of 
the forearm, flexion and extension of elbow, dorsiflexion and palmar flexion of the wrist using 
a goniometer, and their comparison to the corresponding measurements of the subject’s 
healthy forearm. 
 
Figure 1 
Determination of forearm’s pronation and supination angles 
In measuring of pronation, the vertical limb of the goniometer is placed parallel to the long 
axis of the humerus, while the horizontal limb is placed on the back of the wrist (to eliminate 
additional motion at the radiocarpal joint). In the measuring supination the horizontal limb is 
placed on the anterior aspect. The average range of protonation/supination is 90/90 degrees 
(50/50  degrees  necessary  for  activities  of  daily  living). Flynn’s  criteria  for  elbow 
assessment is used to evaluate the clinical significance of outcomes (excellent and  
good comprising satisfactory, and fair and poor comprising unsatisfactory), as well as  
the classification by Price.
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Figure 2 
Determination of A) elbow’s flexion and extension, B) wrist’s dorsiflexion and 
palmar flexion 
Clinical outcome and fracture union will be also assessed by the absence of pain and bony 
tenderness at fracture site. The subjects will be also asked to perform self-assessment of 
perceived pain in the region of study using 10 cm visual analogue scale (VAS) as a measure 
of pain severity.  
1.1.10
Radiographic Evaluations
This  study  will  involve  normal  repeated  radiographic  examinations  of  the  forearm  for 
assessment  of  outcome,  progress  of  fracture  union  and  also  possible  development  of 
complications related to injury or treatment.
Plain Radiographs
The plain radiographs in standard anteroposterior (AP) and lateral projections will be taken 
before and after surgery, followed by repeated radiographs according to table 2. 
The parameters defined from forearm’s plain radiographs are 

fracture reduction and retention

fracture angulation

fracture union as bridging callus by the presence of obliteration of fracture lines 
(union, delayed union, non-union)

increased/decreased radial bow (fracture malunion)

limb-length discrepancy

complications related to injury or treatment (implant-related osteolysis)
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The angulation of the fractures will be measured on anteroposterior and lateral radiographic 
views. Radiographic union will be defined as the presence of bridging callus at all visualized 
cortices on the anteroposterior and lateral radiographic views. Delayed union will be classified 
as incomplete healing at 10 weeks in children <9 years of age and at 12 weeks in children ≥9 
years of age. [23]
At latest follow-up malunion will be quantified by measurement of the amount and location of 
the maximum radial bow in relation to the contralateral, normal forearm as described by 
Schemitsch and Richards. The radial bow will be measured on the anteroposterior radiograph 
of the forearm, which includes the wrist and elbow joints. 
Limb-length discrepancy will be assessed by measurement of the distances between lateral 
epicondyle of the humerus and radial styloid process in both limbs.
MR Imaging
The parameters defined from forearm’s MR images are 

fracture reduction and retention

fracture angulation

fracture union as bridging callus by the presence of obliteration of fracture lines 
(union, delayed union, non-union)

fracture malunion (radial bow, Limb-length discrepancy)

complications related to injury or treatment (implant related osteolysis and detection 
of IM nail failure)

soft-tissue reactions (oedema, abnormal fibrotic tissue, post-traumatic calcification) in 
the surroundings

bioabsorption of the investigational device
Evaluation of Variables
The following variables will be measured from each subject at designed visits in evaluation of 
the efficacy and safety of fixation. The radiographic measurements are performed by an 
experienced paediatric radiologist, familiar with children’s trauma.
1.1.11
Primary Performance Variable
Evaluation of functional and clinical outcome consists of following determinations:
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
Measurements of the range of motion (ROM) in the forearm, expressed as degrees ± SD
o
Loss of supination and pronation of the forearm (graded according to the table 
below), 
o
Loss of flexion and extension of elbow and
o
Loss of dorsiflexion and palmar flexion of the wrist, graded according to the 
Flynn’s criteria (<10 degrees of chance are excellent or good i.e. satisfactory; >10 
degrees of chance are fair or poor i.e. unsatisfactory); and Price’s classification.

General pain and pain at fracture site assessed by VAS, expressed as mm ± SD
o
Duration of post-operative medication for pain
Table 1 
Classification of outcome, graded using a system described by Price [25] 
Outcome
Loss of Forearm Rotation and Symptoms
Excellent
 ≤15° loss of forearm rotation and no complaints with strenuous 
activity
Good
A loss of forearm rotation of 15° to 30° and only mild complaints with 
strenuous physical activity
Fair
A loss of forearm rotation of 30° to 90° and mild complaints during 
activities of daily living
Poor
All other outcomes
 
1.1.12
Secondary Variables
Forearm’s plain radiographs in AP and lateral projections and MRI imaging will be used to 
determine:

Fracture reduction and retention

Fracture angulation, expressed as degrees ± SD (graded according to Table below)

Bony union formation and rate (union, delayed union, non-union, malunion)
1.1.13
Safety Variables
Incidence of adverse events (AE) and serious adverse event (SAE) will be expressed as 
proportion per group. These consist of e.g. complications related to injury or treatment and 
will  be  separated  into  resolved  versus  long-term  or  non-resolved  complications,  which 
included a need for return to the operating room. Monitored AE’s are:
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
Fracture delayed union, nonunion and malunion

Incidence of infection

Intra-operative complications related to fixation hardware

Need for secondary reduction due to fracture instability

Osteolysis

Bioincompatibility reactions

Mechanical implant failure
The potential drop-outs by any reason are recognized and reported, despite the lack of 2-year 
follow-up data, whilst no comparisons at end-point are available.
1.1.14
Other Variables
Other variables documented in CRF are:

Operation time

Number of days lost from usual activities
o
Parents lost working days

Length of hospitalization stay

Complaints in daily living

Esthetics
Statistics
Recommended statistical methods will be applied. All deviations made after approval of the 
CIP will be described and justified in the final study report.
Sample Size Considerations
Primary outcome variable in this study is loss of supination and pronation within 6, 12, 26, 52, 
and 104 weeks after surgery. The non-inferiority margin is set to be 80 % in the calculations 
(=Power).
It is previously known that the forearm pronation in this age group is 81.2 degrees (95% CI 
79.6-82.28)  and  79.6  degrees  (95%  CI  78.8-80.4)  in  girls  and  boys,  respectively.  The 
corresponding supination archs are 90.0 degrees (95% CI 88.0-92.0) and 87.8 degrees (95% 
CI 85.7-89.9). [26] The standard deviation (SD) is 6.1 degrees in pronation and 7.6 degrees in 
supination. We determined that the new method (ActivaNail –intramedullary fixation) should 
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result to the forearm rotational range of motion that is not more than 15 degrees lower, 
compared  to  the  rotational  range  of  motion  in  TEN  group,  according  to  the  Price’s 
classification (<15 degrees of decrease refers to excellent outcome).
Difference between means in the groups is set as 7.0 and the Alpha as 0.05. The sample size 
is estimated to be 13 experimental subjects and 13 controls according to an unpaired two 
sample Student t test. This study population will also be exclusively large enough to recognize 
decrease in the ROM that is clinically significant (>15 degrees of decrease in supination or 
pronation in ActivaNail compared to TEN group).
Statistical Hypothesis
The following hypothesis will be tested for the primary efficacy variable:
H0:
Investigational device is inferior to comparative devices
H1:
Investigational device is non-inferior to comparative devices
The non-inferiority limit is set to 80 %. Thus, non-inferiority is shown if the upper limit of the 
95% confidence interval for the difference is less than or equal to 5 %.
Statistical Methods
All  operated  subjects  who  reach  the  2-year  follow-up  will  be  included  in  the  statistical 
analysis. Study data will be tabulated by treatment groups with descriptive summary statistics. 
The conventional level of 5% will be considered the level of statistical significance. All tests 
will be two-sided. Accordingly, 95% confidence intervals will be used. 
Normality assumptions will be checked using normal probability plot for residuals. The use of 
transformation for a particular variable will be decided after examining the assumptions with 
the original scale of measurement. Analysis may be repeated without possible outliers. 
The primary variable will be analyzed using an analysis of variance model for repeated 
measurements. Treatment differences with 95% confidence intervals will be calculated from 
the model. If the assumptions for the parametric models are not met suitable non-parametric 
models will be used.
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Adverse Events
The safety variables to be evaluated include adverse events (AE), findings from physical and 
radiographic examinations, subjective reports of pain and functional outcome assessments. 
Further, all drop-outs will be reported. The adverse event data will include the following 
displays:

AEs categorized by body system 

AEs categorized by severity grades 1-4 (mild, moderate, severe, life-threatening) 

AEs involving the region under study (RUS) specifically:
o
Fracture delayed union, nonunion and malunion
o
Hardware failure
o
Infection
All Serious Adverse Events (SAE) will be reported within 24 hours to the Sponsor. The SAEs 
include  death,  life-threatening  event,  medically  important  event,  device  malfunction, 
hospitalization,  accidental  exposure,  persistent  disability  or  incapacity,  and  cancer.  In 
emergency SAE cases, the patients are requested to seek help in the Emergency room of the 
University Central Hospital. Any adverse events and their effects are reported using Case 
Report Form (CRF).
Quality Management
Monitoring Arrangements
The sponsor is responsible for the monitoring of this study.  The principal investigator will 
provide sponsor with the data recorded during the study without personal identification data to 
allow the sponsor to check the compliance of the study with the CIP. The sponsor will appoint 
a monitor for assessing the investigator’s compliance with the Clinical Investigation Plan and 
for performing source-data verification. A monitoring plan and report will be prepared.
Data Management
The study data of the CRFs will be stored at the research sites and copies without personal 
identification data will be sent to the sponsor for storing.
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Quality Assurance
Bioretec  has  a  certified  Quality  Management  System  according  to  ISO  13485:2003. 
Investigational devices will be tested according to SOP’s of the Bioretec Ltd using the test 
equipment maintained and calibrated according to relevant SOP’s of Bioretec Ltd.
Discontinuation and Withdrawal of Subjects
A subject may be discontinued (withdrawn) from the study at any time if the subject or the 
investigator believes it is not in the best interest of the subject to continue participation in the 
study. Subjects withdrawn from the study will not be replaced, regardless of the reason for 
withdrawal. All study data provided up to the time of withdrawal will be collected and reported. 
This information will be recorded in the subject’s source documentation and in the CRF. 
Subjects who discontinue their participation or are withdrawn from the trial will be asked to 
participate in a final study visit at 104-week follow-up visit. 
Termination of the Study
The sponsor may terminate individual subject or group of subjects, or the entire investigation, 
at any time for any of the following reasons:

Failure to enrol subjects

Protocol violations

Inaccurate or incomplete data

Unsafe or unethical practices

Questionable safety of the test device

Suspected lack of efficacy of the test device

Administrative decision.
If the investigator terminates the study prematurely, the investigator provides the ethical 
committee and the sponsor with a written statement describing why the study was terminated 
prematurely. Prompt compliance with this requirement is essential so that the sponsor may 
comply with its regulatory obligations.
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CIP Amendments and Deviations
All amendments to the CIP with the justifications will be agreed and recorded between 
sponsor and the principal investigator. Any deviation to this clinical investigation plan made by 
investigators shall be recorded with an explanation for deviation and reported to sponsor. The 
significance of deviation will be determined by sponsor. When appropriate, Ethical Committee 
and other appropriate regulatory bodies are informed. 
Publication Policy
If on completion of the study the data warrants publication, the investigator may publish the 
results in recognized (refereed) scientific journals.  The  investigator shall submit reports, 
abstracts,  or  manuscripts  to  the  sponsor  for  review  prior  submission  for  publication  or 
presentation. The sponsor shall have 60 days to respond with any requested revisions, 
including without limitation, the deletion of confidential information. The principal investigator 
shall  act  in  good  faith  upon  requested  revisions.  The  principal  investigator  shall  delay 
submission of such publication or presentation materials for up to 90 days in order to have a 
patent application(s) filed. 
Subject Injury
In general, if a subject is injured as direct result of the test device, the sponsor will pay for the 
reasonable and necessary medical treatment for the injury, to the extent the expenses are not 
covered by the subject’s medical insurance, a government program, or other responsible third 
party. 
Report Forms
Case report forms (CRF) are records of data of each subject as defined by the CIP. Data to 
be collected in this study will be entered on CRFs. All data recorded is recommended to be 
verifiable in hospital or patient records. The CRFs are required for each study subject. The 
investigator should confirm the content CRF by signing and dating the applicable pages. 
Original completed forms will be maintained by the principal investigator. A copy of each CRF 
without personal identification will be sent to sponsor.
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References
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Koval K.J. and Zuckerman J.D., Handbook of Fractures, 3rd ed. [2006], p. 540.
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21. Mäkelä E.A., Böstman O., Merikanto J., Södergård J., Törmälä P., Rokkanen P., 
XXX11 World Congress of the International College of Surgeons, October 8-12, Year 
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22. Mäkelä E.A., Lautiainen I., Merikanto J., Södergård J., Rokkanen P. Törmälä P.,  
Valtakunnalliset Lääkäripäivät, Helsingin Messukeskus 6-10.1.2003, ”Intramedullary 
Bioabsorbable Nail Fixation of Forearm Fractures in Children”, B18, p. 295  
23. Greenbaum B, Zionts LE, Ebramzadeh E. Open fractures of the forearm in children. J 
Orthop Trauma. 2001;15:111–118.
24. Schemitsch EH, Richards RR. The effect of malunion on functional outcome after plate 
fixation of fractures of both bones of the forearm in adults. J Bone Joint Surg Am 
1992;74(7):1068–78
25. Price CT, Scott DS, Kurzner ME, et al. Malunited forearm fractures in children. J Pediatr 
Orthop. 1990;10:705–712.
26. Soucie JM, Wang D et al. Range of motion measurements: reference values and a 
database for comparison studies. Haemophilia. 2011; 5: 500-507
27. Price CT, Knapp R. Osteotomy for malunited forearm shaft fractures in children. 
Journal of Pediatric Orthopedics, 2006, 26.2: 193-196
28. Matthews L, Kaufer H, Garver D, Sonstegard D. The effect on supination-pronation of 
angular malalignment of fractures of both bones of the forearm. J Bone Joint Surg Am 
1982; 64(1): 14-17
29. Tarr R, Garfinkel A, Sarmiento A. The effects of angular and rotational deformities of 
both bones of the forearm. An in vitro study. J Bone Joint Surg Am 1984; 66(1): 65-70
Appendixes
1. Information Brochure given to trial subject (in Finnish)
2. Informed Consent Form (in Finnish)
3. A228-CRF-1 Case Report Form
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Clinical Investigation Plan
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
Appendix 1: Information Brochure given to trial subject (translated in English)
Oulu University Hospital, department of pediatric orthopaedics and traumatology
Dear attendee,
We have offered you the possibility to attend the study about operative treatment of 
pediatric forearm fractures. The study patients are not in danger of health risks.  
The  study  aims  to  compare  the  new technique  in  treating  of  pediatric  forearm 
fractures with traditional technique. In the new technique, the implants are made of 
biodegradable material whereas the traditional implants are made of titanium. The 
benefit of biodegradable material is that it absorbs via physiological pathways so the 
implant removal surgery is therefore not needed. 
This  study  is  the  first  of  its  kind  conducted  in  Finland.  Because  of  this  the 
participation is very valuable for us. The research gives us knowledge that helps 
patient treatment in the future. 
The  principal  clinical  investigator  is  Juhani  Merikanto  Adjunct  Professor,  Ph.D. 
orthopaedic  and  traumatology.  Coordinating  Investigator  is  Jaakko  Sinikumpu, 
Adjunct  prof.  Ph.D.  pediatric  orthopaedics  and  traumatology,  Oulu  University 
Hospital.
Taking part in the research is entirely voluntary. After the primary surgery, there will 
be six follow-up visits in the out-patient clinic of Oulu University Hospital during the 
next two years. Your doctor will gladly answer any of your questions regarding of the 
study. The written letter of consent is given to you prior the study.
All the medical information and responses will be kept strictly confidential. The data 
collected  in unidentifiable. The  study  plan  was  approved  by  Hospital  Ethics 
Committee of Tampere Hospital District, Tampere, Finland.
In Oulu 
Willy Serlo
Juha-Jaakko Sinikumpu
Professor, Ph.D.
adjunct prof. Ph.D. pediatric orthopaedic and 
Pediatric surgeon
traumatology
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Clinical Investigation Plan
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
Appendix 2: Informed Consent Form (translated in English)
BIOABSORBABLE INTRAMEDULLARY NAIL FIXATION OF 
FOREARM FRACTURES IN CHILDREN 
Contact Information 
Sponsor: 
Bioretec Ltd.
Hermiankatu 22, P.O. Box 135, FI-33721 Tampere, FINLAND Primary contact: Minna Veiranto, Director, 
Clinical Affairs
Tel: +358 40510 3681, E-mail: minna.veiranto@bioretec.com 
Principal Clinical Investigator: 
Juhani Merikanto, Adjunct prof., Ph.D., Pediatric surgeon, orthopaedics and traumatology, 
Näsilinnankatu 35 B 22, 33200 TRE, tel: 044-0200226, fax 03-31164346, juhani.merikanto@pshp.fi 
Coordinating Investigator: 
Jaakko Sinikumpu, Adjunct prof., Ph.D., Pediatric surgeon, orthopaedics and traumatology, tel: 08 
3152011, juha-jaakko.sinikumpu@ppshp.fi
Institutions, in which the clinical investigation will be conducted, and investigators: 
Oulu University Hospital, Oulu, Finland, Department of Paediatrics, Surgery and Orthopaedics
P.o. Box 23, FIN-90029, OYS, Oulu, FINLAND
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Päijät-Häme Central Hospital, Department of Surgery, Unit of Paediatric Surgery, Keskussairaalankatu 
7, FIN-15850, Lahti, FINLAND 
-Antti Kyrö, M.D., Ph.D., Orthopaedic surgeon
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Clinical Investigation Plan
Bioabsorbable Intramedullary Nail Fixation of Forearm Fractures in Children
THE LETTER OF CONSENT
THE NAME OF THE STUDY: Operative treatment of forearm shaft fractures in children and 
Adolescents
THE STUDY ORGANIZATION: Oulu University Hospital, Oulu, Finland/
Päijät-Häme Central Hospital, Lahti, Finland
MAIN INVESTIGATORS: 
Juha-Jaakko Sinikumpu, Ph.D., adjunct professor, pediatric orthopaedics and traumatology, 
pediatric surgeon 
Linda Korhonen, M.B., Ph.D. candidate
Juhani Merikanto, Ph.D., adjunct professor, orthopaedic surgery, pediatric surgeon
I have been given written letter of consent. I give my approval that my medical information is 
used in this study.
I understand that the participation is voluntary. I have the right to interrupt the participation at 
any time of the study.
I also understand that my medical information and responses will be kept strictly confidential. I 
give permission for members of the research team to have access to my responses. 
I agree for the data collected from me to be used in future medical research. 
I agree to participate the research. 
Place _______________________________
Date    _____/______ 200__ 
_________________________________
Signature of the attendee 
_________________________________
Name 
_________________________________
Date of birth
_________________________________
_________________________________
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