Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures

Distal Radius Fractures Clinical Trial

— DRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00524719
• Other study ID #: GEN # 05-014
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: April 3, 2019

Study information

• Verified date: May 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: April 3, 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

1. Over 18 years of age with skeletal maturity, and consenting to participate.

2. 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.

3. 21 days or less between injury and surgery.

4. The patient must be medically fit for anaesthesia.

5. The patient must have the mental faculties to participate in post- operative evaluation.

Patient exclusion criteria:

1. Significant bone disorder (osteomalacia, hyperparathyroidism) which may impair bone healing (not including osteoporosis).

2. Open fracture.

3. Neurovascular injury requiring repair in same limb.

4. Ipsilateral limb injury.

5. Active infection in area of surgical approaches.

6. 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:

1. Palmar tilt < 00.

2. Radial inclination < 150.

3. Radial shortening > 5 mm.

4. Articular step or gap > or= 2 mm.

Fracture exclusion criteria:

1. Fractures with apex dorsal angulation ("Smith fracture") will be excluded as they are not amenable to treatment with all three methods.

2. 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).

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Open Reduction and Internal Fixation
Fixation with volar locked plate
• Non-Spanning External Fixation
Radio-radial external fixation
• Closed Reduction with Percutaneous Fixation
Percutaneous intrafocal pinning (Kapandji technique)

Locations

Country	Name	City	State
Canada	McGill University Health Centre - Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Orthopaedic Trauma Association

Country where clinical trial is conducted

Canada, 

References & Publications (60)

Abbaszadegan H, Jonsson U, von Sivers K. Prediction of instability of Colles' fractures. Acta Orthop Scand. 1989 Dec;60(6):646-50. — View Citation

Board T, Kocialkowski A, Andrew G. Does Kapandji wiring help in older patients? A retrospective comparative review of displaced intra-articular distal radial fractures in patients over 55 years. Injury. 1999 Dec;30(10):663-9. — View Citation

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. — View Citation

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. — View Citation

Christensen OM, Kunov A, Hansen FF, Christiansen TC, Krasheninnikoff M. Occupational therapy and Colles' fractures. Int Orthop. 2001;25(1):43-5. — View Citation

Cooney WP. External fixation of distal radial fractures. Clin Orthop Relat Res. 1983 Nov;(180):44-9. — View Citation

Cummings SR, Kelsey JL, Nevitt MC, O'Dowd KJ. Epidemiology of osteoporosis and osteoporotic fractures. Epidemiol Rev. 1985;7:178-208. Review. — View Citation

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. — View Citation

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. English, French. — View Citation

Fernández DL. Fractures of the distal radius: operative treatment. Instr Course Lect. 1993;42:73-88. Review. — View Citation

Franck WM, Dahlen C, Amlang M, Friese F, Zwipp H. [Distal radius fracture--is non-bridging articular external fixator a therapeutic alternative? A prospective randomized study]. Unfallchirurg. 2000 Oct;103(10):826-33. German. — View Citation

Friberg S, Lundström B. Radiographic measurements of the radio-carpal joint in normal adults. Acta Radiol Diagn (Stockh). 1976 Mar;17(2):249-56. — View Citation

Gliatis JD, Plessas SJ, Davis TR. Outcome of distal radial fractures in young adults. J Hand Surg Br. 2000 Dec;25(6):535-43. — View Citation

Goeree R, O'Brien B, Pettit D, Cuddy L, Ferraz M, Adachi JD. An assessment of the burden of illness due to osteoporosis in Canada. J Soc Obstet Gynaecol Can 1996; 18 suppl (July):15-24. 4.

Greatting MD, Bishop AT. Intrafocal (Kapandji) pinning of unstable fractures of the distal radius. Orthop Clin North Am. 1993 Apr;24(2):301-7. Review. — View Citation

Handoll HH, Madhok R. Surgical interventions for treating distal radial fractures in adults. Cochrane Database Syst Rev. 2003;(3):CD003209. Review. Update in: Cochrane Database Syst Rev. 2009;(3):CD003209. — View Citation

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. Review. — View Citation

Heim D. [Plate osteosynthesis of distal radius fractures--incidence, indications and results]. Swiss Surg. 2000;6(6):304-14. German. — View Citation

Hove LM, Nilsen PT, Furnes O, Oulie HE, Solheim E, Mölster 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. — View Citation

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. — View Citation

Jebsen RH, Taylor N, Trieschmann RB, Trotter MJ, Howard LA. An objective and standardized test of hand function. Arch Phys Med Rehabil. 1969 Jun;50(6):311-9. — View Citation

Jupiter JB, Lipton H. The operative treatment of intraarticular fractures of the distal radius. Clin Orthop Relat Res. 1993 Jul;(292):48-61. Review. — View Citation

Jupiter JB. Plate fixation of fractures of the distal aspect of the radius: relative indications. J Orthop Trauma. 1999 Nov;13(8):559-69. — View Citation

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. — View Citation

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. French. — View Citation

Kapoor H, Agarwal A, Dhaon BK. Displaced intra-articular fractures of distal radius: a comparative evaluation of results following closed reduction, external fixation and open reduction with internal fixation. Injury. 2000 Mar;31(2):75-9. — View Citation

Kazuki K, Kusunoki M, Yamada J, Yasuda M, Shimazu A. Cineradiographic study of wrist motion after fracture of the distal radius. J Hand Surg Am. 1993 Jan;18(1):41-6. — View Citation

Knirk JL, Jupiter JB. Intra-articular fractures of the distal end of the radius in young adults. J Bone Joint Surg Am. 1986 Jun;68(5):647-59. — View Citation

Larsen CF, Lauritsen J. Epidemiology of acute wrist trauma. Int J Epidemiol. 1993 Oct;22(5):911-6. — View Citation

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. — View Citation

Ludvigsen TC, Johansen S, Svenningsen S, Saetermo R. External fixation versus percutaneous pinning for unstable Colles' fracture. Equal outcome in a randomized study of 60 patients. Acta Orthop Scand. 1997 Jun;68(3):255-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

MacDermid JC. Development of a scale for patient rating of wrist pain and disability. J Hand Ther. 1996 Apr-Jun;9(2):178-83. Review. — View Citation

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

McQueen M, Caspers J. Colles fracture: does the anatomical result affect the final function? J Bone Joint Surg Br. 1988 Aug;70(4):649-51. — View Citation

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. — View Citation

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. — View Citation

Millroy P, Coleman S, Ivers R. The Sauvé-Kapandji operation. Technique and results. J Hand Surg Br. 1992 Aug;17(4):411-4. — View Citation

Nguyen TV, Center JR, Sambrook PN, Eisman JA. Risk factors for proximal humerus, forearm, and wrist fractures in elderly men and women: the Dubbo Osteoporosis Epidemiology Study. Am J Epidemiol. 2001 Mar 15;153(6):587-95. — View Citation

Oskam J, Kingma J, Klasen HJ. Fracture of the distal forearm: epidemiological developments in the period 1971-1995. Injury. 1998 Jun;29(5):353-5. — View Citation

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. — View Citation

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. English, French. — View Citation

Pogue DJ, Viegas SF, Patterson RM, Peterson PD, Jenkins DK, Sweo TD, Hokanson JA. Effects of distal radius fracture malunion on wrist joint mechanics. J Hand Surg Am. 1990 Sep;15(5):721-7. — View Citation

Prommersberger KJ, Lanz U. [Biomechanical aspects of malunited distal radius fracture. A review of the literature]. Handchir Mikrochir Plast Chir. 1999 Jul;31(4):221-6. Review. German. — View Citation

Ray NF, Chan JK, Thamer M, Melton LJ 3rd. Medical expenditures for the treatment of osteoporotic fractures in the United States in 1995: report from the National Osteoporosis Foundation. J Bone Miner Res. 1997 Jan;12(1):24-35. — View Citation

Rayhack JM. The history and evolution of percutaneous pinning of displaced distal radius fractures. Orthop Clin North Am. 1993 Apr;24(2):287-300. Review. — View Citation

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. — View Citation

Rosenthal AH, Chung KC. Intrafocal pinning of distal radius fractures: a simplified approach. Ann Plast Surg. 2002 Jun;48(6):593-9. — View Citation

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. — View Citation

Stoffelen DV, Broos PL. Closed reduction versus Kapandji-pinning for extra-articular distal radial fractures. J Hand Surg Br. 1999 Feb;24(1):89-91. — View Citation

Stucki G, Liang MH, Phillips C, Katz JN. The Short Form-36 is preferable to the SIP as a generic health status measure in patients undergoing elective total hip arthroplasty. Arthritis Care Res. 1995 Sep;8(3):174-81. — View Citation

Svensson O, Ahrengart L, Ekholm C, Andersson GL, Höglund M, Jonsson U, Juhlin L, Kopylov P, Lagerström C, Lundborg G, Made C, Mallmin H, Räf L, Törnkvist 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. — View Citation

Swiontkowski MF, Engelberg R, Martin DP, Agel J. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999 Sep;81(9):1245-60. — View Citation

Szabo RM. Extra-articular fractures of the distal radius. Orthop Clin North Am. 1993 Apr;24(2):229-37. Review. — View Citation

Taleisnik J, Watson HK. Midcarpal instability caused by malunited fractures of the distal radius. J Hand Surg Am. 1984 May;9(3):350-7. — View Citation

Tornetta P 3rd, Klein DM, Stein AB, McQueen M. Distal radius fracture. J Orthop Trauma. 2002 Sep;16(8):608-11. — View Citation

van Leeuwen PA, Reynders PA, Rommens PM, Broos PL. Operative treatment of Smith-Goyrand fractures. Injury. 1990 Nov;21(6):358-60. — View Citation

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. — View Citation

* Note: There are 60 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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