Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

NCT06931418 | Recruiting DMC

• 1 other identifier: UW 24-153
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture; Rehabilitation; Patient outcomes; Physiotherapy; Occupational therapy; Orthopaedic fracture repair

Outcome Measures

Primary Outcomes (3)

• Region-specific patient reported functional outcome score

  Physical function and symptoms measured by Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH), an 11-item patient-reported measure with a total score ranging from 0 (no disability) to 100 (most severe disability).

  At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

• Range of motion

  Subjects' wrist range of motion, including: pronation, supination, flexion, and extension will be measured by allied health therapists at each follow-up timepoint.

  At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

• Grip strength

  Grip strength will be measured using a dynamometer weekly for the ESP group and weekly from 6 weeks onwards for the EMP group.

  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 Outcomes (4)

• Health-related Quality of Life Measured by SF-12 Chinese (HK) Version

  At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

• Radiographic outcomes

  At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

• Incidence of complications

  At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

• Qualitative self-reported compliance

  At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

Study Arms (2)

Early Strengthening Protocol (ESP)

EXPERIMENTAL

Early use of strength and passive stretching will be encouraged after their initial assessment by rehabilitation therapists within 2 weeks of their discharge.

Other: Early Strengthening Protocol

Early Motion Protocol (Control)

ACTIVE COMPARATOR

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.

Other: Early Motion Protocol

Interventions

Early Strengthening Protocol OTHER

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 Strengthening Protocol (ESP)

Early Motion Protocol OTHER

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.

Early Motion Protocol (Control)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35510735 BACKGROUND

• 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.

  PMID: 29212691 BACKGROUND

• 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.

  PMID: 21991417 BACKGROUND

• 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.

  PMID: 23481405 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Christian Prof. Fang, MBBS(HK), FRCS(Edinburgh), FHK

  Dept of Orthopaedics and Traumatology, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Prof. Fang, MBBS(HK)

CONTACT

+852 22554581; cfang@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are randomly assigned to either one of the interventional arm and will not be informed of the randomisation result. Surgeons and assessors are blinded to the intervention allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Double-blind randomised control trial with 50 patients in two interventional arm

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 17, 2025
• Study Start: May 22, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 1 year of study completion
• Access Criteria: Additional information available upon reasonable request of principal investigator

Locations

HK (1)