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NCT Number: NCT06931418

Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital, The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Christian Prof. FANG, MBBS(HK)

CONTACT

[email protected]

+852 22554581

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Region-specific patient reported functional outcome score

    Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

    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).

  2. Range of motion

    Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

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

  3. 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

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

Secondary outcomes

  1. 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

    12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome).

  2. Radiographic outcomes

    Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

    Subjects' X-rays will be assessed for fracture healing, implant migration, and fracture displacement.

  3. Incidence of complications

    Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

    Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation

  4. Qualitative self-reported compliance

    Time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months

    Subjects' self-reported score on their compliance to the rehabilitation exercises based on a Likert Scale of 1 (Did not follow) to 5 (Fully comply)

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Prof. Fang, MBBS(HK)

CONTACT

[email protected]

+852 22554581

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Acronym: EMPRESS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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