Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius
NCT ID: NCT06931418
Last Updated: 2025-04-25
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-05-22
2027-10-31
Brief Summary
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Detailed Description
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The investigators have performed early motion protocol (EMP) rehabilitation in the last decade in the investigation center for post-operative fracture distal radius fixation patients. The early motion protocol allows immediate active mobilization without a period of immobilization or splint protection. Despite early mobilization rehabilitation, there are a subset of patients who develop significant stiffness and pain with poor functional outcomes, especially in the early post-operative period. Moreover, some patients may also develop complex regional pain syndrome (CRPS) albeit early active mobilization. Thus, an early strengthening protocol (ESP) was developed to allow for immediate strengthening and passive mobilization exercises post-operatively with physiotherapist and occupational therapist guidance. Herein this study, the investigators hope to demonstrate the safety and efficacy of an ESP rehabilitation compared to EMP for post-operative distal radius fracture fixation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Surgeons and assessors are blinded to the intervention allocated.
Study Groups
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Early Strengthening Protocol (ESP)
Early use of strength and passive stretching will be encouraged after their initial assessment by rehabilitation therapists within 2 weeks of their discharge.
Early Strengthening Protocol
Patients in the ESP intervention arm will undergo active and passive exercises as well as strengthening exercises after their initial assessment by rehabilitation therapists within 2 weeks of their discharge. Early use of strength and passive stretching will be encouraged immediately after allocation.
Early Motion Protocol (Control)
Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists, while passive mobilization and strengthening are started at the post-operative 8-10-week period.
Early Motion Protocol
Patients are instructed for active flexion, extension, supination, pronation and finger flexion of the operated wrist along with motion of the shoulder and elbow after operation. Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists. Passive mobilization and strengthening is started at the post-operative 8-10-week period.
Interventions
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Early Strengthening Protocol
Patients in the ESP intervention arm will undergo active and passive exercises as well as strengthening exercises after their initial assessment by rehabilitation therapists within 2 weeks of their discharge. Early use of strength and passive stretching will be encouraged immediately after allocation.
Early Motion Protocol
Patients are instructed for active flexion, extension, supination, pronation and finger flexion of the operated wrist along with motion of the shoulder and elbow after operation. Active mobilization is continued for the initial post-operative 6 weeks with allied health therapists. Passive mobilization and strengthening is started at the post-operative 8-10-week period.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with an isolated closed injury, displaced, distal radius fracture (AO/OTA Classification 23-A1-3, B1-2, C1-2) without articular comminution
* Requires operative fixation
* Able to give consent
Exclusion Criteria
* Neurological injury or pre-existing neurological conditions to the upper limb
* Underlying osteoarthritis of the wrist
* Unfit for surgical anesthesia
* Subacute fractures with delayed presentation (\>2 weeks since initial injury)
* Unable to consent
* Refuse surgical intervention
* Unable to follow commands for rehabilitation
* Fixation construct or injuries requiring immobilization after surgery, such as unfixed distal ulna head or shaft fractures that require splintage or distal radio-ulnar joint instability planned for immobilization
50 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Prof. Christian Xinshuo Fang
Clinical Associate Professor
Principal Investigators
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Christian Prof. Fang, MBBS(HK), FRCS(Edinburgh), FHK
Role: PRINCIPAL_INVESTIGATOR
Dept of Orthopaedics and Traumatology, Queen Mary Hospital
Locations
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Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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References
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Tsutsui S, Kawasaki K, Yamakoshi K, Uchiyama E, Aoki M, Inagaki K. Impact of double-tiered subchondral support procedure with a polyaxial locking plate on the stability of distal radius fractures using fresh cadaveric forearms: Biomechanical and radiographic analyses. J Orthop Sci. 2016 Sep;21(5):603-8. doi: 10.1016/j.jos.2016.07.015. Epub 2016 Aug 12.
Baumbach SF, Synek A, Traxler H, Mutschler W, Pahr D, Chevalier Y. The influence of distal screw length on the primary stability of volar plate osteosynthesis--a biomechanical study. J Orthop Surg Res. 2015 Sep 8;10:139. doi: 10.1186/s13018-015-0283-8.
Ramavath A, Howard N, Lipscombe S. Biomechanical considerations for strategies to improve outcomes following volar plating of distal radius fractures. J Orthop. 2019 May 11;16(5):445-450. doi: 10.1016/j.jor.2019.04.006. eCollection 2019 Sep-Oct.
Handoll HH, Elliott J. Rehabilitation for distal radial fractures in adults. Cochrane Database Syst Rev. 2015 Sep 25;2015(9):CD003324. doi: 10.1002/14651858.CD003324.pub3.
Watson N, Haines T, Tran P, Keating JL. A Comparison of the Effect of One, Three, or Six Weeks of Immobilization on Function and Pain After Open Reduction and Internal Fixation of Distal Radial Fractures in Adults: A Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Jul 5;100(13):1118-1125. doi: 10.2106/JBJS.17.00912.
Sorensen TJ, Ohrt-Nissen S, Ardenso KV, Laier GH, Mallet SK. Early Mobilization After Volar Locking Plate Osteosynthesis of Distal Radial Fractures in Older Patients-A Randomized Controlled Trial. J Hand Surg Am. 2020 Nov;45(11):1047-1054.e1. doi: 10.1016/j.jhsa.2020.05.009. Epub 2020 Jul 4.
Bhan K, Hasan K, Pawar AS, Patel R. Rehabilitation Following Surgically Treated Distal Radius Fractures: Do Immobilization and Physiotherapy Affect the Outcome? Cureus. 2021 Jul 7;13(7):e16230. doi: 10.7759/cureus.16230. eCollection 2021 Jul.
Andrade-Silva FB, Rocha JP, Carvalho A, Kojima KE, Silva JS. Influence of postoperative immobilization on pain control of patients with distal radius fracture treated with volar locked plating: A prospective, randomized clinical trial. Injury. 2019 Feb;50(2):386-391. doi: 10.1016/j.injury.2018.12.001. Epub 2018 Dec 4.
Blomstrand J, Kjellby Wendt G, Karlsson J, Wangdell J, Fagevik Olsen M. Pain, hand function, activity performance and apprehensiveness, in patients with surgically treated distal radius fractures. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):247-252. doi: 10.1080/2000656X.2022.2060992. Epub 2022 May 5.
Stinton SB, Graham PL, Moloney NA, Maclachlan LR, Edgar DW, Pappas E. Longitudinal recovery following distal radial fractures managed with volar plate fixation. Bone Joint J. 2017 Dec;99-B(12):1665-1676. doi: 10.1302/0301-620X.99B12.BJJ-2017-0348.R1.
Dillingham C, Horodyski M, Struk AM, Wright T. Rate of Improvement following Volar Plate Open Reduction and Internal Fixation of Distal Radius Fractures. Adv Orthop. 2011;2011:565642. doi: 10.4061/2011/565642. Epub 2011 Aug 11.
Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013 Apr;38(4):641-9. doi: 10.1016/j.jhsa.2012.12.032. Epub 2013 Mar 6.
Other Identifiers
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UW 24-153
Identifier Type: -
Identifier Source: org_study_id
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