Clinical trial NCT01103297: 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius
Official title: A Prospective Multicenter Case-series of Patients Treated With the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Distal Radius Fractures
Keywords: Distal radius fracture
Double row plate
Volar approach
DVR plate
Postoperative complications [MeSH]
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to is to evaluate the postoperative loss of reduction rate in patients with distal radius fractures treated using the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®.

Detailed description: The treatment of choice for distal radius fractures is anatomic reduction with stable fixation. This is commonly achieved via open reduction and internal fixation with angle-stable designed locking plates using either a volar or dorsal approach. Frequent complications of tendinitis are associated with the latter approach. Palmar application of angle-stable plates reduces this problem of extensor tendon irritation; however a high incidence of fracture collapse has been documented. Currently, there are no existing locking plates that provide sufficient stability particularly for complex fractures. Insufficient fragment fixation can result in loss of reduction due to interfragmentary movement and lead to mal- or nonunion.

The Variable Angle LCP Two-Column Volar DR plate (VA LCP DR) is a novel development of the LCP Distal Radius Plate System, which is designed to treat a wide variety of distal radius fracture patterns. Because of its design (ie, low plate and screw profile, polished surface, rounded edges, various locking options), not only can the potential for tendon adhesions and soft tissue irritation be minimized, the plate can address fragments individually for each fracture type. Thus, the versatility of VA LCP facilitates the reduction and stabilization of even the most complex fractures, including those in osteoporotic bone.

This prospective case-series will evaluate the performance of the new VA LCP DR plate in the treatment of complex articular fractures of the distal radius. The primary objective of this study involves the documentation of postoperative loss of reduction; functional outcomes, quality of life and rate of complications associated with fracture fixation will also be assessed as part of the secondary study aims.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with closed, partial or complete articular distal radius fractures classified as: AO 23 B3 and AO 23 C1, C2, C3 confirmed by CT scan
* Definitive primary fracture treatment with a VA LCP DR
* The patient is willing and able to participate in the study follow-up examinations according to the protocol
* The patient is able to understand and read the local language at an elementary level
* The patient or his/her legal guardian is willing and able to give his informed consent to participate in the study
* Woman must be one of the following:
* Postmenopausal defined as amenorrhea for at least 6 months before screening and a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status
* Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
* Abstinent (at the discretion of the investigator) or,
* If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), a double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel, or male partner with a vasectomy.
* Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test, or a negative urine pregnancy test at screening.

Exclusion Criteria:

* Previous ipsilateral distal radius fracture
* Other fractures of the ipsilateral side (except ulna)
* Pathologic fracture due to malignancy
* The patient suffers from a polytrauma
* The patient is affected by drug or alcohol abuse
* The patient suffers from active malignancy
* Neurological and psychiatric disorders
* The patient has participated in any other device or drug related clinical trial within the previous month
* The patient is a prisoner
* Breast feeding woman

Primary outcomes:
measure: Loss of reduction
timeFrame: over 1 year
Secondary outcomes:
measure: Rate of fracture fixation complications
timeFrame: Baseline
measure: Wrist function
timeFrame: 12 weeks
measure: Grip strength
timeFrame: 12 weeks
measure: Wrist pain and disability in functional activities
timeFrame: Baseline
measure: Quality of Life
timeFrame: Baseline
measure: Implantation and system feedback
timeFrame: Baseline
measure: Rate of fracture fixation complications
timeFrame: 12 weeks
measure: Rate of fracture fixation complications
timeFrame: 1 year
measure: Wrist function
timeFrame: 1 year
measure: Grip strength
timeFrame: 1 year
measure: Wrist pain and disability in functional activities
timeFrame: 12 weeks
measure: Wrist pain and disability in functional activities
timeFrame: 1 year
measure: Quality of Life
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Unfallkrankenhaus Graz
city: Berlin
country: Germany
facility: Charite Berlin
city: Münster
country: Germany
facility: Universitätssklinikum Münster
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Spital Zollikerberg
Study officials:
affiliation: Massachusetts General Hospital, Orthopaedic Surgery, Yawkey Center, Suite 2100, 55 Fruit Street, Boston, MA 02114, USA
name: Jesse B Jupiter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spital Zollikerberg, Unfallchirurgie, Trichtenhauserstrasse 20, CH-8125 Zollikerberg, Switzerland
name: Andreas Schierz, MD
role: PRINCIPAL_INVESTIGATOR
References: