Distal Radius FractureLIMPER-DRFNCT05150925
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
A study testing Cast treatment, Immediate mobilization and Volar plating in people with Distal Radius Fracture, run by Tampere University Hospital at 5 sites in 2 countries.
Trial summary
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Cast treatment, Immediate mobilization and Volar plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Dec 2021to 10 Feb 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Who cannot join
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological fracture
- Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
Show all 9Show fewer
- Ipsilateral fracture in upper extremity
- Associated fractures of the ulna (except fractures of the PSU)
- Polytrauma
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Finland3 sites
Teemu Karjalainen
Jyväskylä
Kuopio University Hospital
Kuopio
Laura Kärnä
Tampere
About this study
Official title: Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
Read the detailed description
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
- Conditions
- Distal Radius Fracture
- Being tested
- Cast treatment, Immediate mobilization, Volar plating
- Keywords
- distal radius fracture, volar plating, surgery
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast treatmentOther
Dorsal cast placed in OR
Immediate mobilizationOther
Immediate mobilization postoperatively without casting
Volar platingProcedure or surgery
Volar plating of distal radius fracture
| Study group | Role | What they receive |
|---|---|---|
| Immediate mobilization after distal radius fracture treated with volar locking plate | Experimental | Not described Receives: Other: Immediate mobilization; Procedure: Volar plating |
| 2 weeks cast immobilization after distal radius fracture treated with volar locking plate | Active comparator | Not described Receives: Other: Cast treatment; Procedure: Volar plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated wrist evaluation questionnaire
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.
Measured: 2 months
Total lenght of the sick leave
Total number of days of work during the 1 year study period
Measured: 12 months
Secondary outcomes (26)
Patient-rated wrist evaluation questionnaire
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.
Measured: 4 weeks
Patient-rated wrist evaluation questionnaire
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.
Measured: 6 months
Patient-rated wrist evaluation questionnaire
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.
Measured: 12 months
Return to work
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
Measured: 4 weeks
Return to work
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
Measured: 2 months
Return to work
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
Measured: 6 months
Return to work
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work.
Measured: 12 months
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Measured: 4 weeks
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Measured: 2 months
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Measured: 6 months
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Measured: 12 months
Self-perceived working ability
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
Measured: 4 weeks
Self-perceived working ability
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
Measured: 2 months
Self-perceived working ability
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
Measured: 6 months
Self-perceived working ability
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled).
Measured: 12 months
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Measured: 4 weeks
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Measured: 2 months
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Measured: 6 months
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Measured: 12 months
Patient-acceptable symptom state
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?
Measured: 2 months
Patient-acceptable symptom state
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?
Measured: 6 months
Patient-acceptable symptom state
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)?
Measured: 12 months
Work capacity
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
Measured: 4 weeks
Work capacity
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
Measured: 2 months
Work capacity
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
Measured: 6 months
Work capacity
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Dec 2021
- Primary completion10 Feb 2026
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital, Jyväskylä Central Hospital, Sundsvall Hospital, Danderyd Hospital
- Responsible party
- Principal investigator, Aleksi Reito, Tampere University Hospital
- Investigators
- Aleksi Reito, Study director, Tampere University HospitalLaura Kärnä, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150925
- Sponsor's protocol ID
- R21111
- Acronym
- LIMPER-DRF
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2021
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available on reasonable request.
Publications
Karna L, Launonen AP, Karjalainen T, Luokkala T, Ponkilainen V, Halonen L, Helminen M, Mattila VM, Reito A. LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate - a study protocol for a prospective, randomised, controlled trial. BMJ Open. 2022 Nov 11;12(11):e064440. doi: 10.1136/bmjopen-2022-064440.
PubMed 36368761
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate - a Study Protocol for a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05150925
- Acronym / sponsor ID
- LIMPER-DRF / R21111
- Conditions
- Distal Radius Fracture
- Keywords
- distal radius fracture, volar plating, surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Kuopio University Hospital, Jyväskylä Central Hospital, Sundsvall Hospital, Danderyd Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 9 Dec 2021 (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 aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
Detailed description
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate mobilization after distal radius fracture treated with volar locking plate | Experimental | Other: Immediate mobilization, Procedure: Volar plating |
| 2 weeks cast immobilization after distal radius fracture treated with volar locking plate | Active comparator | Other: Cast treatment, Procedure: Volar plating |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological 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 |
|---|---|---|
| Cast treatmentDorsal cast placed in OR | Other | 2 weeks cast immobilization after distal radius fracture treated with volar locking plate |
| Immediate mobilizationImmediate mobilization postoperatively without casting | Other | Immediate mobilization after distal radius fracture treated with volar locking plate |
| Volar platingVolar plating of distal radius fracture | Procedure or surgery | 2 weeks cast immobilization after distal radius fracture treated with volar locking plate, Immediate mobilization after distal radius fracture treated with volar locking plate |
Primary outcome
Patient-rated wrist evaluation questionnaire
Time frame: 2 months
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities.
Total lenght of the sick leave
Time frame: 12 months
Total number of days of work during the 1 year study period
26 secondary outcomes
Patient-rated wrist evaluation questionnaire
Time frame: 4 weeks
Patient-rated wrist evaluation questionnaire
Time frame: 6 months
Patient-rated wrist evaluation questionnaire
Time frame: 12 months
Return to work
Time frame: 4 weeks
Return to work
Time frame: 2 months
Return to work
Time frame: 6 months
Return to work
Time frame: 12 months
Complications
Time frame: 4 weeks
Complications
Time frame: 2 months
Complications
Time frame: 6 months
Complications
Time frame: 12 months
Self-perceived working ability
Time frame: 4 weeks
Self-perceived working ability
Time frame: 2 months
Self-perceived working ability
Time frame: 6 months
Self-perceived working ability
Time frame: 12 months
Visual analogue pain scale
Time frame: 4 weeks
Visual analogue pain scale
Time frame: 2 months
Visual analogue pain scale
Time frame: 6 months
Visual analogue pain scale
Time frame: 12 months
Patient-acceptable symptom state
Time frame: 2 months
Patient-acceptable symptom state
Time frame: 6 months
Patient-acceptable symptom state
Time frame: 12 months
Work capacity
Time frame: 4 weeks
Work capacity
Time frame: 2 months
Work capacity
Time frame: 6 months
Work capacity
Time frame: 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 11 Feb 2026.
- Derived from this study: PubMed 36368761Karna L, Launonen AP, Karjalainen T, Luokkala T, Ponkilainen V, Halonen L, Helminen M, Mattila VM, Reito A. LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate - a study protocol for a prospective, randomised, controlled trial. BMJ Open. 2022 Nov 11;12(11):e064440. doi: 10.1136/bmjopen-2022-064440.
- Individual participant dataSharing planned: Yes. Data is available on reasonable request.
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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.
Aleksi Reito study director
Tampere University Hospital
Laura Kärnä, MD principal investigator
Tampere University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast treatment, Immediate mobilization and Volar plating in people with Distal Radius Fracture, run by Tampere University Hospital at 5 sites in 2 countries.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland, 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-rated wrist evaluation questionnaire (time frame: 2 months). The study lists 2 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 NCT05150925, which also lists 1 linked publication.
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 11 Feb 2026.