Distal Radius FracturesDRFNCT00524719
Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures
A study testing Open Reduction and Internal Fixation, Non-Spanning External Fixation and Closed Reduction with Percutaneous Fixation in people with Distal Radius Fractures, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Open Reduction and Internal Fixation, Non-Spanning External Fixation and Closed Reduction with Percutaneous Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
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
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.
Read the 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.
- Conditions
- Distal Radius Fractures
- Being tested
- Open Reduction and Internal Fixation, Non-Spanning External Fixation, Closed Reduction with Percutaneous Fixation
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction and Internal FixationProcedure or surgery
Fixation with volar locked plate
Non-Spanning External FixationProcedure or surgery
Radio-radial external fixation
Closed Reduction with Percutaneous FixationProcedure or surgery
Percutaneous intrafocal pinning (Kapandji technique)
| Study group | Role | What they receive |
|---|---|---|
| Open, internal fixation volar plate | Active comparator | Open reduction and internal fixation (ORIF) with volar locked plate Receives: Procedure: Open Reduction and Internal Fixation |
| Closed reduction with external fixator | Active comparator | Surgical procedure - Closed reduction and non-spanning external fixation (Ex-FIX) Receives: 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 Receives: Procedure: Closed Reduction with Percutaneous Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 6 weeks; 3,6,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2016
- Study completion3 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Principal investigator, Greg K. Berry, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Greg K Berry, MD FRCSC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524719
- Sponsor's protocol ID
- GEN # 05-014
- Acronym
- DRF
- Status last verified
- May 2020
- First submitted
- 4 Sep 2007
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Larsen CF, Lauritsen J. Epidemiology of acute wrist trauma. Int J Epidemiol. 1993 Oct;22(5):911-6. doi: 10.1093/ije/22.5.911.
PubMed 8282472Nguyen 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. doi: 10.1093/aje/153.6.587.
PubMed 11257067Cummings 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.
PubMed 3902494Papadimitropoulos EA, Coyte PC, Josse RG, Greenwood CE. Current and projected rates of hip fracture in Canada. CMAJ. 1997 Nov 15;157(10):1357-63.
PubMed 9371065Goeree 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.
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. doi: 10.1359/jbmr.1997.12.1.24.
PubMed 9240722van Leeuwen PA, Reynders PA, Rommens PM, Broos PL. Operative treatment of Smith-Goyrand fractures. Injury. 1990 Nov;21(6):358-60. doi: 10.1016/0020-1383(90)90118-e.
PubMed 2276796Oskam J, Kingma J, Klasen HJ. Fracture of the distal forearm: epidemiological developments in the period 1971-1995. Injury. 1998 Jun;29(5):353-5. doi: 10.1016/s0020-1383(97)00212-x.
PubMed 9813678Gliatis JD, Plessas SJ, Davis TR. Outcome of distal radial fractures in young adults. J Hand Surg Br. 2000 Dec;25(6):535-43. doi: 10.1054/jhsb.2000.0373.
PubMed 11106514Szabo RM. Extra-articular fractures of the distal radius. Orthop Clin North Am. 1993 Apr;24(2):229-37.
PubMed 8479721Kapoor 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. doi: 10.1016/s0020-1383(99)00207-7.
PubMed 10748808Kazuki 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. doi: 10.1016/0363-5023(93)90242-U.
PubMed 8423316McQueen M, Caspers J. Colles fracture: does the anatomical result affect the final function? J Bone Joint Surg Br. 1988 Aug;70(4):649-51. doi: 10.1302/0301-620X.70B4.3403617.
PubMed 3403617Board 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. doi: 10.1016/s0020-1383(99)00167-9.
PubMed 10707240Stoffelen DV, Broos PL. Closed reduction versus Kapandji-pinning for extra-articular distal radial fractures. J Hand Surg Br. 1999 Feb;24(1):89-91. doi: 10.1016/s0266-7681(99)90045-1.
PubMed 10190614
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00524719
- Acronym / sponsor ID
- DRF / GEN # 05-014
- Conditions
- Distal Radius Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Jan 2007
- Primary completion
- Dec 2016 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open, internal fixation volar plate | Active comparator | Procedure: Open Reduction and Internal FixationOpen reduction and internal fixation (ORIF) with volar locked plate |
| Closed reduction with external fixator | Active comparator | Procedure: Non-Spanning External FixationSurgical procedure - Closed reduction and non-spanning external fixation (Ex-FIX) |
| Closed reduction percutaneous pinning | Active comparator | Procedure: Closed Reduction with Percutaneous FixationSurgical procedure - Closed reduction with percutaneous pinning (CRPP) and the application of a cast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Reduction and Internal FixationFixation with volar locked plate | Procedure or surgery | Open, internal fixation volar plate |
| Non-Spanning External FixationRadio-radial external fixation | Procedure or surgery | Closed reduction with external fixator |
| Closed Reduction with Percutaneous FixationPercutaneous intrafocal pinning (Kapandji technique) | Procedure or surgery | Closed reduction percutaneous pinning |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Background: PubMed 8282472Larsen CF, Lauritsen J. Epidemiology of acute wrist trauma. Int J Epidemiol. 1993 Oct;22(5):911-6. doi: 10.1093/ije/22.5.911.
- Background: PubMed 11257067Nguyen 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. doi: 10.1093/aje/153.6.587.
- Background: PubMed 3902494Cummings 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.
- Background: PubMed 9371065Papadimitropoulos EA, Coyte PC, Josse RG, Greenwood CE. Current and projected rates of hip fracture in Canada. CMAJ. 1997 Nov 15;157(10):1357-63.
- BackgroundGoeree 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.
- Background: PubMed 9240722Ray 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. doi: 10.1359/jbmr.1997.12.1.24.
- Background: PubMed 2276796van Leeuwen PA, Reynders PA, Rommens PM, Broos PL. Operative treatment of Smith-Goyrand fractures. Injury. 1990 Nov;21(6):358-60. doi: 10.1016/0020-1383(90)90118-e.
- Background: PubMed 9813678Oskam J, Kingma J, Klasen HJ. Fracture of the distal forearm: epidemiological developments in the period 1971-1995. Injury. 1998 Jun;29(5):353-5. doi: 10.1016/s0020-1383(97)00212-x.
- Background: PubMed 11106514Gliatis JD, Plessas SJ, Davis TR. Outcome of distal radial fractures in young adults. J Hand Surg Br. 2000 Dec;25(6):535-43. doi: 10.1054/jhsb.2000.0373.
- Background: PubMed 8479721Szabo RM. Extra-articular fractures of the distal radius. Orthop Clin North Am. 1993 Apr;24(2):229-37.
- Background: PubMed 10748808Kapoor 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. doi: 10.1016/s0020-1383(99)00207-7.
- Background: PubMed 8423316Kazuki 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. doi: 10.1016/0363-5023(93)90242-U.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg K Berry, MD FRCSC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction and Internal Fixation, Non-Spanning External Fixation and Closed Reduction with Percutaneous Fixation in people with Distal Radius Fractures, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524719, which also lists 60 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.