Radius Fracture DistalEXTENDNCT05371938
Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up
A study testing Volar locking plate and external fixation in people with Radius Fracture Distal and Surgery, run by Olof Skoldenberg at 1 site in Sweden.
Trial summary
A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Radius Fracture Distal, Surgery, Surgery--Complications
- What is being tested?
- Volar locking plate and external fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DS center
- acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees.
- Age 20-70
- SÖS center
- Age 50-74 for women and 60-74 for men
- injury only after fall from a standing height
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- wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axial shortening
- good knowledge of written and spoken swedish
- fracture diagnosed within 72 hours from injury
- patient resident within the catchment area of SÖS center
Who cannot join
- DS center:
- no previous fracture of either wrist
- ipsilateral acute fracture of the upper extremity
- medicated with warfarin
- unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems)
- open fracture
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- fracture that was not amenable by both methods (distal fragment to small or to comminuted)
- SÖS center:
- former disability of either wrist
- other concomitant injuries
- rheumatoid arthritis or other severe joint disorder
- Dementia or pfeiffer score under 5 points
- drug abuse, alcohol abuse or psychiatric disorder
- dependency in activity of daily living
- medical condition contradicting general anesthesia
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics
Stockholm, 182 88
Olof Sköldenberg, Professor, 004612357245, olof.skoldenberg@ki.se
Sara Severin, MD, 0046812356504, sara.l.severin@regionstockholm.se
About this study
Official title: Longterm Follow up for Displaced Distal Radius Fracture Randomized to Surgery With Volar Locking Plate or External Fixation
A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.
Read the detailed description
Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength).
Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359
- Conditions
- Radius Fracture Distal, Surgery, Surgery--Complications, Treatment Complication, Tendon Injuries, Tendon Rupture
- Being tested
- Volar locking plate, external fixation
- Medical subject headings
- Wrist Fractures, Tendon Injuries, Surgical Wound Infection, Reflex Sympathetic Dystrophy, Causalgia, Joint Dislocations, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar locking plateProcedure or surgery
Volar locking plate is the intervention
external fixationProcedure or surgery
surgery with external fixation
| Study group | Role | What they receive |
|---|---|---|
| Volar Locking Plate | Experimental | Surgery with volar locking plate Receives: Procedure: Volar locking plate |
| External fixation | Active comparator | Surgery with external fixation Receives: Procedure: external fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability of the arm shoulder and hand (DASH)
PROM Patient Rated outcome Measurement. A 30-item questionnaire to assess musculoskeletal disorders in upper limbs. It also has two 4-items optional modules to assess function and symptoms in athletes, artists and workers. Item response range from 1 (no difficult) to 5 (unable). The total score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 10 years after initial surgery
Secondary outcomes (6)
Patient rated wrist evaluation (PRWE)
A patient rated outcome measurement(PROM) a subjective test of function by a 15-item questionnaire. PRWE is specific for wrist evaluation. It consists of two subscales - pain and function. Total score ranges from 0 (no disability) to 100 (severe disability)
Measured: 10 years after initial surgery
Radiological assesment
x-ray of both wrists, AP and lateral. Assessing radial inclination, dorsal tilt, ulnar variance. Osteoarthritis of the radioulnar joint and DRU-joint, fractures in carpus/ulna. VISI/DISI and SL-dissociation.
Measured: 10 years after initial surgery
Objective tests of range of motion (ROM)
pronation and supination, ulnar- and radial deviation, volar flexion and doral extension of both wrists with a goniometer, units will be degrees.
Measured: 10 years after initial surgery
Journal investigation
A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries.
Measured: 0-10 years after initial surgery
EQ-5D
A health related quality of life questionnaire. EQ-5D is the correct name and not an abbreviation. 5 dimensions of health is assessed (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) in three levels (no problems/some or moderate problems/extreme problems). The responses of EQ-5D can be converted to a singel number - a index value and compared with a value set. The index value reflects how good or bad the health statues is. There is also a visual analogue scale on overall health with the scale 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: 10 years after initial surgery
Objective test of grip strength
Test of grip strength by GRIPPIT units is Newton. Grip strength will be measured bilateral and presented as maximum, mean and value after 10 seconds.
Measured: 10 year after initial surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olof Skoldenberg
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Association for Survivors of Accident and Injury
- Responsible party
- Sponsor-investigator, Olof Skoldenberg, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371938
- Sponsor's protocol ID
- Handledsstudien 1
- Acronym
- EXTEND
- Status last verified
- May 2022
- First submitted
- 1 Apr 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Follow up for Displaced Distal Radius Fracture Randomized to Surgery With Volar Locking Plate or External Fixation
- ClinicalTrials.gov ID
- NCT05371938
- Acronym / sponsor ID
- EXTEND / Handledsstudien 1
- Conditions
- Radius Fracture Distal, Surgery, Surgery--Complications, Treatment Complication, Tendon Injuries, Tendon Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Olof SkoldenbergUniversity, hospital or other
- Collaborators
- The Swedish Association for Survivors of Accident and Injury
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 12 May 2022 (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.
A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.
Detailed description
Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength).
Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volar Locking Plate | Experimental | Procedure: Volar locking plateSurgery with volar locking plate |
| External fixation | Active comparator | Procedure: external fixationSurgery with external fixation |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DS center
- acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees.
- Age 20-70
- SÖS center
- Age 50-74 for women and 60-74 for men
Key exclusion criteria (15 listed)
- no previous fracture of either wrist
- ipsilateral acute fracture of the upper extremity
- medicated with warfarin
- unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems)
- open fracture
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 |
|---|---|---|
| Volar locking plateVolar locking plate is the intervention | Procedure or surgery | Volar Locking Plate |
| external fixationsurgery with external fixation | Procedure or surgery | External fixation |
Primary outcome
Disability of the arm shoulder and hand (DASH)
Time frame: 10 years after initial surgery
PROM Patient Rated outcome Measurement. A 30-item questionnaire to assess musculoskeletal disorders in upper limbs. It also has two 4-items optional modules to assess function and symptoms in athletes, artists and workers. Item response range from 1 (no difficult) to 5 (unable). The total score ranges from 0 (no disability) to 100 (most severe disability).
6 secondary outcomes
Patient rated wrist evaluation (PRWE)
Time frame: 10 years after initial surgery
Radiological assesment
Time frame: 10 years after initial surgery
Objective tests of range of motion (ROM)
Time frame: 10 years after initial surgery
Journal investigation
Time frame: 0-10 years after initial surgery
EQ-5D
Time frame: 10 years after initial surgery
Objective test of grip strength
Time frame: 10 year after initial surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar locking plate and external fixation in people with Radius Fracture Distal and Surgery, run by Olof Skoldenberg at 1 site in Sweden.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 May 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olof Sköldenberg, Professor (0046812357245, olof.skoldenberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability of the arm shoulder and hand (DASH) (time frame: 10 years after initial surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2022.