Clinical trial NCT02382341: BIOSURE™ HEALICOIL™ PK Bone In-growth Study
Official title: A Radiographic Study of Patients Treated With the BIOSURE™ HEALICOIL™ PK Interference Screw for ACL Repair With Soft Tissue Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deficiency of Anterior Cruciate Ligament
Keywords: ACL
BIOSURE
HEALICOIL
PEEK
In-Growth
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing ACL reconstruction

Brief summary: The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as measured by CT scans. Patients' improvement in pain and function will also be followed through various outcome measures.

Detailed description: The primary objective of the current study is to assess bone in-growth in the BIOSURE™ HEALICOIL™ Interference screw in the tibial tunnel of patients undergoing ACL reconstruction with soft tissue grafts; tunnel widening and change in IKDC knee and subjective scores will also be documented.

Eligibility criteria: Inclusion Criteria:

* ACL tear requiring surgical reconstruction with semitendinosus/gracilis graft.
* Willing and able to give voluntary informed consent to participate in this study
* Willing and able, in the opinion of the investigator, to cooperate with study procedures and willing to return to study site for all post-operative study visits.
* Subject is between 18 and 50 years at the time of surgery
* ASA group 0-2 (limited medical illness).

Exclusion Criteria:

* Revision ACL reconstruction
* Cartilage injury (IKDC Grade IV lesion\> 2 cm2)
* Current malignant disease
* Rheumatoid arthritis
* Osteonecrosis or Avascular Necrosis
* Ankylosing spondylitis
* Subject is Obese; BMI \> 35
* Subject is pregnant or plans to become pregnant during the study
* Subject has received medical treatment within 6 weeks of enrollment with any of the following:

Glucocorticoids Growth hormone

* Participating in another investigational trial or on-going study that would interfere with the assessment of the primary and secondary outcomes

Primary outcomes:
measure: Bone In-growth measured by CT scans
timeFrame: 1 year
Secondary outcomes:
measure: Bone In-growth measured by CT scans
timeFrame: 6 months
measure: Improvement in IKDC Knee Examination scoring from baseline to 1 year post-operatively
timeFrame: 1 year
measure: Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 1 year post-operatively
timeFrame: 1 year
measure: Improvement in IKDC Knee Examination scoring from baseline to 2 years post-operatively
timeFrame: 2 years
measure: Improvement in the IKDC Subjective Knee Evaluation scoring from baseline to 2 years post-operatively
timeFrame: 2 Years
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Martin Lind, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lind M, Nielsen T, Sorensen OG, Mygind-Klavsen B, Fauno P, Leake-Gardner S. Bone ingrowth into open architecture PEEK interference screw after ACL reconstruction. J Exp Orthop. 2020 Sep 18;7(1):68. doi: 10.1186/s40634-020-00285-z.