Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

Official title

Randomized Controlled Trial for Post-operative Fracture Distal Radius Rehabilitation - The Early Motion Protocol Rehabilitation vs. Early Strengthening Study (EMPRESS Trial)

Overview

The primary objective of this study is to demonstrate safety and efficacy of an early strengthening and passive mobilization rehabilitation program for post-operative distal radius fracture fixation surgery compared to current conventional rehabilitation.

Detailed description

Functional outcome after distal radius fracture fixation has often been variable with multiple factors affecting final results. Early mobilization rehabilitation protocols have been the gold standard after fracture fixation surgery. Rehabilitation protocols vary from center to center's own practices. However, these commonly encompass an early mobilization protocol or otherwise known as accelerated rehabilitation or enhanced recovery after surgery (ERAS) programs. Such programs comprise of a short duration of immobilization followed by a period of active mobilization before strengthening exercises are employed.

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.

Interventions

• Other 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.
• Other 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.

Primary outcome measures

• Region-specific patient reported functional outcome score [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
• Range of motion [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
• Grip strength [Time frame: ESP group: At post-op weekly from 1 to 12 weeks, 6 months and 12 months ; EMP group: At post-op weekly from 6 to 12 weeks, 6 months and 12 months]

Secondary outcome measures (4)

• Health-related Quality of Life Measured by SF-12 Chinese (HK) Version [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
• Radiographic outcomes [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
• Incidence of complications [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]
• Qualitative self-reported compliance [Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months]

Eligibility criteria

Inclusion criteria

• Aged 50 years or older
• 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

• History of previous hand or wrist surgery
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Queen Mary Hospital, The University of Hong Kong — Hong Kong

Publications

• 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. PMID 27523260
• 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. PMID 26351239
• 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. PMID 31528050
• 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. PMID 26403335
• 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. PMID 29975268
• 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. PMID 32636043
• 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. PMID 34367829
• 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. PMID 30558805

Identifiers

NCT: NCT06931418 · UW 24-153

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗