Distal Radius FractureEMPRESSNCT06931418
Early Strengthening Rehabilitation Training for Post-operative Fracture Distal Radius
A study testing Early Strengthening Protocol and Early Motion Protocol in people with Distal Radius Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Early Strengthening Protocol and Early Motion Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 May 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Christian Prof. FANG, MBBS(HK), +852 22554581, cfang@hku.hk
About this study
Official title: Randomized Controlled Trial for Post-operative Fracture Distal Radius Rehabilitation - The Early Motion Protocol Rehabilitation vs. Early Strengthening Study (EMPRESS Trial)
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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Early Strengthening Protocol, Early Motion Protocol
- Keywords
- Distal radius fracture, Rehabilitation, Patient outcomes, Physiotherapy, Occupational therapy, Orthopaedic fracture repair
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Strengthening ProtocolOther
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Early Motion Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
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).
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Radiographic outcomes
Subjects' X-rays will be assessed for fracture healing, implant migration, and fracture displacement.
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Incidence of complications
Incidence of wound breakdown, infection, CRPS, implant failure including screw breakage, and re-operation
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Qualitative self-reported compliance
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)
Measured: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start22 May 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Model description
- Double-blind randomised control trial with 50 patients in two interventional arm
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Christian Xinshuo Fang, The University of Hong Kong
- Investigators
- Christian Prof. Fang, MBBS(HK), FRCS(Edinburgh), FHK, Principal investigator, Dept of Orthopaedics and Traumatology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931418
- Sponsor's protocol ID
- UW 24-153
- Acronym
- EMPRESS
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized dataset to be included as supplementary data in final publication
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.
PubMed 27523260Baumbach 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.
PubMed 26351239Ramavath 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.
PubMed 31528050Handoll 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.
PubMed 26403335Watson 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.
PubMed 29975268Sorensen 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.
PubMed 32636043Bhan 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.
PubMed 34367829Andrade-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.
PubMed 30558805Blomstrand 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.
PubMed 35510735Stinton 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.
PubMed 29212691Dillingham 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.
PubMed 21991417Sorensen 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.
PubMed 23481405
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for Post-operative Fracture Distal Radius Rehabilitation - The Early Motion Protocol Rehabilitation vs. Early Strengthening Study (EMPRESS Trial)
- ClinicalTrials.gov ID
- NCT06931418
- Acronym / sponsor ID
- EMPRESS / UW 24-153
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture, Rehabilitation, Patient outcomes, Physiotherapy, Occupational therapy, Orthopaedic fracture repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomised control trial with 50 patients in two interventional arm
| Arm | Type | Receives |
|---|---|---|
| Early Strengthening Protocol (ESP) | Experimental | Other: Early Strengthening ProtocolEarly use of strength and passive stretching will be encouraged after their initial assessment by rehabilitation therapists within 2 weeks of their discharge. |
| Early Motion Protocol (Control) | Active comparator | Other: Early Motion ProtocolActive 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Early Strengthening ProtocolPatients 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 Strengthening Protocol (ESP) |
| Early Motion ProtocolPatients 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. | Other | Early Motion Protocol (Control) |
Primary outcome
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).
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.
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Background: PubMed 27523260Tsutsui 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.
- Background: PubMed 26351239Baumbach 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.
- Background: PubMed 31528050Ramavath 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.
- Background: PubMed 26403335Handoll 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.
- Background: PubMed 29975268Watson 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.
- Background: PubMed 32636043Sorensen 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.
- Background: PubMed 34367829Bhan 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.
- Background: PubMed 30558805Andrade-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.
- Background: PubMed 35510735Blomstrand 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.
- Background: PubMed 29212691Stinton 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.
- Background: PubMed 21991417Dillingham 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.
- Background: PubMed 23481405Sorensen 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.
- Individual participant dataSharing planned: Yes. Anonymized dataset to be included as supplementary data in final publication
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Christian Prof. Fang, MBBS(HK), FRCS(Edinburgh), FHK principal investigator
Dept of Orthopaedics and Traumatology, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Strengthening Protocol and Early Motion Protocol in people with Distal Radius Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Prof. Fang, MBBS(HK) (+852 22554581, cfang@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Region-specific patient reported functional outcome score (time frame: At post-op 2 weeks, 6 weeks , 12 weeks and 6 months and 12 months). The study lists 3 primary outcomes in all. 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 NCT06931418, which also lists 12 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 25 Apr 2025.