- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00524719
Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures (DRF)
A Prospective Randomised Trial Comparing Open Reduction and Internal Fixation, Non-Spanning External Fixation, and Closed Reduction With Percutaneous Fixation in Displaced Distal Radius Fractures With Joint Congruity
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.
Study Overview
Status
Conditions
Detailed Description
Fractures of the distal radius, the most common fracture to occur in adults, are increasing in incidence and cost due to ageing of the population and the link with senile osteoporosis. Young adults also suffer these injuries albeit involving higher-energy mechanisms. Closed reduction and casting is often unsuccessful in maintaining adequate alignment and length, both of which are crucial to a successful outcome. Thus, there has been a trend toward surgical treatment of these fractures. In fractures with preserved joint congruity, 3 fixation options exist: percutaneous pinning (Kapandji technique), non-spanning external fixation, and locked-plates. Locked-plates represent a significant advance in the fixation of fractures, especially in osteopenic bone, although their role in distal radius fractures has yet to be defined adequately. The Cochrane Group undertook a meta-analysis of RC trials "to determine when, and if so what type of, surgical intervention is the most appropriate treatment for fractures of the distal radius in adults." The authors concluded: "there is a need for good quality evidence for the surgical management of these fractures." The aim of this randomized clinical trial is to compare the functional, clinical, and radiographic outcomes of these 3 methods. The results will clearly guide surgeons in the choice of optimal technique.
This multicenter prospective randomized trial will involve the Canadian Orthopaedic Trauma Society (COTS), an association of trauma surgeons involved in collaborative outcomes research with a proven track record of research and publication. Patients with a displaced distal radius fracture with joint congruity who meet all eligibility criteria and provide consent to participate will be randomly assigned to reduction and fixation with one of three methods: volar locked-plate, percutaneous pinning and cast (Kapandji intra-focal technique), or non-spanning external fixation. Patients will undergo physiotherapy according to protocols adapted to fixation technique. Evaluation at fixed intervals will include functional, clinical, and radiological parameters. Functional evaluation will include the PRWE, DASH, and SMFA questionnaires. Clinical outcome will evaluate range of motion, pinch and grip strength, and dexterity. Standard radiographic parameters will be measured. The primary outcome measure will be functional outcome as measured with the PRWE. Appropriate statistical analyses will be performed on the data. Sample size calculation reveals the need for 108 patients per treatment arm. A census of the centers committed to the study predicts a 12-18 month recruitment period. Patient follow-up will end at 2 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1A4
- McGill University Health Centre - Montreal General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patient Inclusion Criteria:
- 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.
- 21 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.
Patient exclusion criteria:
- 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.
Fracture inclusion criteria:
Patients sustaining a displaced AO type A2 A3 C1 or C2 distal metaphyseal radius fracture with preserved joint congruity before (52) or after closed reduction are eligible for inclusion. Radiographic criteria for an unacceptable closed reduction include:
- Palmar tilt < 00.
- Radial inclination < 150.
- Radial shortening > 5 mm.
- Articular step or gap > or= 2 mm.
Fracture exclusion criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Open, internal fixation volar plate
Open reduction and internal fixation (ORIF) with volar locked plate
|
Fixation with volar locked plate
|
Active Comparator: Closed reduction with external fixator
Surgical procedure - Closed reduction and non-spanning external fixation (Ex-FIX)
|
Radio-radial external fixation
|
Active Comparator: Closed reduction percutaneous pinning
Surgical procedure - Closed reduction with percutaneous pinning (CRPP) and the application of a cast
|
Percutaneous intrafocal pinning (Kapandji technique)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
Time Frame: 6 weeks; 3,6,12 and 24 months
|
6 weeks; 3,6,12 and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 6 weeks; 3,6,12 and 24 months
|
6 weeks; 3,6,12 and 24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Greg K Berry, MD FRCSC, McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications and helpful links
General Publications
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- Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. doi: 10.1093/oxfordjournals.epirev.a036281. No abstract available.
- Papadimitropoulos EA, Coyte PC, Josse RG, Greenwood CE. Current and projected rates of hip fracture in Canada. CMAJ. 1997 Nov 15;157(10):1357-63.
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- Szabo RM. Extra-articular fractures of the distal radius. Orthop Clin North Am. 1993 Apr;24(2):229-37.
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- Jupiter JB, Lipton H. The operative treatment of intraarticular fractures of the distal radius. Clin Orthop Relat Res. 1993 Jul;(292):48-61.
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- Svensson O, Ahrengart L, Ekholm C, Andersson GL, Hoglund M, Jonsson U, Juhlin L, Kopylov P, Lagerstrom C, Lundborg G, Made C, Mallmin H, Raf L, Tornkvist H. [Malpractice in connection with radius fractures must be reduced. Clear guidelines for treatment and follow-up are required]. Lakartidningen. 2000 Apr 12;97(15):1800-4, 1807-9. Swedish.
- Fernandez DL. Fractures of the distal radius: operative treatment. Instr Course Lect. 1993;42:73-88. No abstract available.
- Hastings H 2nd, Leibovic SJ. Indications and techniques of open reduction. Internal fixation of distal radius fractures. Orthop Clin North Am. 1993 Apr;24(2):309-26.
- McMurtry RY, Jupiter JB. Fractures of the distal radius. In: Skeletal Trauma, ed by Browner B, Jupiter J, Levine A, Trafton P. Philadelphia, WB Saunders, 1991, pp 1063-1094
- Handoll HH, Madhok R. Surgical interventions for treating distal radial fractures in adults. Cochrane Database Syst Rev. 2003;(3):CD003209. doi: 10.1002/14651858.CD003209.
- Tornetta P 3rd, Klein DM, Stein AB, McQueen M. Distal radius fracture. J Orthop Trauma. 2002 Sep;16(8):608-11. doi: 10.1097/00005131-200209000-00013. No abstract available.
- Kapandji A. [Internal fixation by double intrafocal plate. Functional treatment of non articular fractures of the lower end of the radius (author's transl)]. Ann Chir. 1976 Nov;30(11-12):903-8. No abstract available. French.
- Rayhack JM. The history and evolution of percutaneous pinning of displaced distal radius fractures. Orthop Clin North Am. 1993 Apr;24(2):287-300.
- Lenoble E, Dumontier C, Goutallier D, Apoil A. Fracture of the distal radius. A prospective comparison between trans-styloid and Kapandji fixations. J Bone Joint Surg Br. 1995 Jul;77(4):562-7.
- Peyroux LM, Dunaud JL, Caron M, Ben Slamia I, Kharrat M. The Kapandji technique and its evolution in the treatment of fractures of the distal end of the radius. Report on a series of 159 cases. Ann Chir Main. 1987;6(2):109-22. doi: 10.1016/s0753-9053(87)80023-6. English, French.
- Millroy P, Coleman S, Ivers R. The Sauve-Kapandji operation. Technique and results. J Hand Surg Br. 1992 Aug;17(4):411-4. doi: 10.1016/s0266-7681(05)80264-5.
- Epinette JA, Lehut JM, Cavenaile M, Bouretz JC, Decoulx J. Pouteau-Colles fracture: double-closed "basket-like" pinning according to Kapandji. Apropos of a homogeneous series of 70 cases. Ann Chir Main. 1982;1(1):71-83. doi: 10.1016/s0753-9053(82)80047-1. English, French.
- Greatting MD, Bishop AT. Intrafocal (Kapandji) pinning of unstable fractures of the distal radius. Orthop Clin North Am. 1993 Apr;24(2):301-7.
- Dowdy PA, Patterson SD, King GJ, Roth JH, Chess D. Intrafocal (Kapandji) pinning of unstable distal radius fractures: a preliminary report. J Trauma. 1996 Feb;40(2):194-8. doi: 10.1097/00005373-199602000-00004.
- Rosenthal AH, Chung KC. Intrafocal pinning of distal radius fractures: a simplified approach. Ann Plast Surg. 2002 Jun;48(6):593-9. doi: 10.1097/00000637-200206000-00005.
- Sanders RA, Keppel FL, Waldrop JI. External fixation of distal radial fractures: results and complications. J Hand Surg Am. 1991 May;16(3):385-91. doi: 10.1016/0363-5023(91)90002-s.
- Cooney WP. External fixation of distal radial fractures. Clin Orthop Relat Res. 1983 Nov;(180):44-9.
- Vaughan PA, Lui SM, Harrington IJ, Maistrelli GL. Treatment of unstable fractures of the distal radius by external fixation. J Bone Joint Surg Br. 1985 May;67(3):385-9. doi: 10.1302/0301-620X.67B3.3997946.
- Jakim I, Pieterse HS, Sweet MB. External fixation for intra-articular fractures of the distal radius. J Bone Joint Surg Br. 1991 Mar;73(2):302-6. doi: 10.1302/0301-620X.73B2.2005161.
- McQueen MM, Simpson D, Court-Brown CM. Use of the Hoffman 2 compact external fixator in the treatment of redisplaced unstable distal radial fractures. J Orthop Trauma. 1999 Sep-Oct;13(7):501-5. doi: 10.1097/00005131-199909000-00007.
- Kamano M, Honda Y, Kazuki K, Yasuda M. Palmar plating for dorsally displaced fractures of the distal radius. Clin Orthop Relat Res. 2002 Apr;(397):403-8. doi: 10.1097/00003086-200204000-00047.
- Jupiter JB. Plate fixation of fractures of the distal aspect of the radius: relative indications. J Orthop Trauma. 1999 Nov;13(8):559-69. doi: 10.1097/00005131-199911000-00009. No abstract available.
- Rikli DA, Regazzoni P. Fractures of the distal end of the radius treated by internal fixation and early function. A preliminary report of 20 cases. J Bone Joint Surg Br. 1996 Jul;78(4):588-92.
- Hove LM, Nilsen PT, Furnes O, Oulie HE, Solheim E, Molster AO. Open reduction and internal fixation of displaced intraarticular fractures of the distal radius. 31 patients followed for 3-7 years. Acta Orthop Scand. 1997 Feb;68(1):59-63. doi: 10.3109/17453679709003977.
- Heim D. [Plate osteosynthesis of distal radius fractures--incidence, indications and results]. Swiss Surg. 2000;6(6):304-14. doi: 10.1024/1023-9332.6.6.304. German.
- Campbell DA. Open reduction and internal fixation of intra articular and unstable fractures of the distal radius using the AO distal radius plate. J Hand Surg Br. 2000 Dec;25(6):528-34. doi: 10.1054/jhsb.2000.0485.
- Carter PR, Frederick HA, Laseter GF. Open reduction and internal fixation of unstable distal radius fractures with a low-profile plate: a multicenter study of 73 fractures. J Hand Surg Am. 1998 Mar;23(2):300-7. doi: 10.1016/S0363-5023(98)80131-7.
- McQueen MM. Redisplaced unstable fractures of the distal radius. A randomised, prospective study of bridging versus non-bridging external fixation. J Bone Joint Surg Br. 1998 Jul;80(4):665-9. doi: 10.1302/0301-620x.80b4.8150.
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- MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. doi: 10.1097/00005131-199811000-00009.
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- MacDermid JC, Richards RS, Donner A, Bellamy N, Roth JH. Responsiveness of the short form-36, disability of the arm, shoulder, and hand questionnaire, patient-rated wrist evaluation, and physical impairment measurements in evaluating recovery after a distal radius fracture. J Hand Surg Am. 2000 Mar;25(2):330-40. doi: 10.1053/jhsu.2000.jhsu25a0330.
- MacDermid JC, Donner A, Richards RS, Roth JH. Patient versus injury factors as predictors of pain and disability six months after a distal radius fracture. J Clin Epidemiol. 2002 Sep;55(9):849-54. doi: 10.1016/s0895-4356(02)00445-6.
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- Taleisnik J, Watson HK. Midcarpal instability caused by malunited fractures of the distal radius. J Hand Surg Am. 1984 May;9(3):350-7. doi: 10.1016/s0363-5023(84)80222-1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEN # 05-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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