Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures

NCT00524719 | Completed

• 1 other identifier: GEN # 05-014
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

Distal radius fractures are the most common fracture to occur in the adult population, and those which are displaced but maintain joint congruity are the most common subtype. Locking-plate technology represents a true advance in the fixation of these fractures, especially in view of the ever increasing incidence of these injuries in an ageing and osteoporotic population throughout Europe and North America. These plates permit rigid fixation, even in osteopenic bone, while avoiding any tethering of soft tissues, as seen with external fixation and percutaneous pinning. For these reasons, this mode of fracture fixation has rapidly gained popularity. Unfortunately, there is presently little evidence to support their use over the more traditional methods of fixation (percutaneous pinning, external fixation). In addition, the technique for their application is more invasive and their cost is considerably greater than these latter two techniques. As such, it is pertinent to evaluate, in a scientifically sound fashion, the outcome of fixation with the three types of implant included in this study. The results of this clinical trial will allow the orthopaedic community to confidently recommend the fixation method which provides the optimal functional, clinical, and radiographic outcome for a patient suffering a displaced distal radius with preserved joint congruity. Null hypothesis: There is no difference in the functional, clinical, and radiographic outcomes of the three treatment methods. Hypothesis: Given the locking nature of modern screw-plate constructs, which produce excellent fixation even in osteopenic bone and permit early range of motion exercises; and given that plate fixation, in contrast to external fixation and percutaneous pinning, does not tether muscle, tendon, or capsule; plate fixation with a volar fixed-angle device should permit earlier and more aggressive rehabilitation and more rapid and complete regain of hand and wrist function when compared to stabilization with external fixation or percutaneous pinning.

Conditions

Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Variable: Validated functional outcome tools to be used: patient rated wrist evaluation (PRWE) disability shoulder, arm, hand (DASH) short musculoskeletal functional assessment (SMFA)

  6 weeks; 3,6,12 and 24 months

Secondary Outcomes (1)

• Secondary Outcome Measures: Clinical outcome: measurement of range of motion (ROM), strength (grip and pinch), and dexterity (Jebsen hand function-checkers sub-test). Radiologic outcome: X-ray parameters

  6 weeks; 3,6,12 and 24 months

Study Arms (3)

Open, internal fixation volar plate

ACTIVE COMPARATOR

Open reduction and internal fixation (ORIF) with volar locked plate

Procedure: Open Reduction and Internal Fixation

Closed reduction with external fixator

ACTIVE COMPARATOR

Surgical procedure - Closed reduction and non-spanning external fixation (Ex-FIX)

Procedure: Non-Spanning External Fixation

Closed reduction percutaneous pinning

ACTIVE COMPARATOR

Surgical procedure - Closed reduction with percutaneous pinning (CRPP) and the application of a cast

Procedure: Closed Reduction with Percutaneous Fixation

Interventions

Open Reduction and Internal Fixation PROCEDURE

Fixation with volar locked plate

Open, internal fixation volar plate

Non-Spanning External Fixation PROCEDURE

Radio-radial external fixation

Closed reduction with external fixator

Closed Reduction with Percutaneous Fixation PROCEDURE

Percutaneous intrafocal pinning (Kapandji technique)

Closed reduction percutaneous pinning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age with skeletal maturity, and consenting to participate.
• A displaced distal metaphyseal radius fracture (AO type A2, A3, C1, C2--- appendix 1) with a congruous joint surface (\< 2 mm displacement) either before or after closed reduction.
• days or less between injury and surgery.
• The patient must be medically fit for anaesthesia.
• The patient must have the mental faculties to participate in post- operative evaluation.

You may not qualify if:

• Significant bone disorder (osteomalacia, hyperparathyroidism) which may impair bone healing (not including osteoporosis).
• Open fracture.
• Neurovascular injury requiring repair in same limb.
• Ipsilateral limb injury.
• Active infection in area of surgical approaches.
• Prior wrist injury or degenerative condition, or congenital wrist anomaly.
• Palmar tilt \< 00.
• Radial inclination \< 150.
• Radial shortening \> 5 mm.
• Articular step or gap \> or= 2 mm.
• Fractures with apex dorsal angulation ("Smith fracture") will be excluded as they are not amenable to treatment with all three methods.
• Less than 1 cm of intact volar cortex on the distal fragment as this is the minimum necessary for non-spanning external fixation (40, 48).

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

McGill University Health Centre - Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

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MeSH Terms

Conditions

Wrist Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Greg K Berry, MD FRCSC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDCM FRCSC

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: April 3, 2019
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)