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Active, not recruitingNCT05150925LIMPER-DRFUpdated Feb 11, 2026

Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate

An interventional study of Cast treatment and Immediate mobilization in Distal Radius Fracture, sponsored by Tampere University Hospital. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Distal Radius Fracture

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Keywords

  • distal radius fracture
  • volar plating
  • surgery
03

In context

Wrist Fractures

323 studies on the registry are indexed under Wrist Fractures; 71 are open to participants now.

This study's planned enrollment of 240 is above the median of 64 across 261 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Intra- or extra articular DRF (Colles, Smith, Volar barton)
  • operative treatment justified

Exclusion criteria

Exclusion Criteria:

  • 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
  • Ipsilateral fracture in upper extremity
  • Associated fractures of the ulna (except fractures of the PSU)
  • Polytrauma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Immediate mobilization after distal radius fracture treated with volar locking plate

    Other: Immediate mobilization · Procedure: Volar plating

  • Active comparator
    2 weeks cast immobilization after distal radius fracture treated with volar locking plate

    Other: Cast treatment · Procedure: Volar plating

Interventions

  • OtherCast treatment

    Dorsal cast placed in OR

  • OtherImmediate mobilization

    Immediate mobilization postoperatively without casting

  • ProcedureVolar plating

    Volar plating of distal radius fracture

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

  2. Total lenght of the sick leave

    Total number of days of work during the 1 year study period

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 12 months

  4. 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.

    Time frame: 4 weeks

  5. 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.

    Time frame: 2 months

  6. 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.

    Time frame: 6 months

  7. 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.

    Time frame: 12 months

  8. Complications

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

    Time frame: 4 weeks

  9. Complications

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

    Time frame: 2 months

  10. Complications

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

    Time frame: 6 months

  11. Complications

    Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome

    Time frame: 12 months

  12. 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).

    Time frame: 4 weeks

  13. 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).

    Time frame: 2 months

  14. 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).

    Time frame: 6 months

  15. 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).

    Time frame: 12 months

  16. Visual analogue pain scale

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

    Time frame: 4 weeks

  17. Visual analogue pain scale

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

    Time frame: 2 months

  18. Visual analogue pain scale

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

    Time frame: 6 months

  19. Visual analogue pain scale

    Overall pain during last 7 days in a scale from 0 to 100 (worst)

    Time frame: 12 months

  20. 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)?

    Time frame: 2 months

  21. 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)?

    Time frame: 6 months

  22. 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)?

    Time frame: 12 months

  23. 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.

    Time frame: 4 weeks

  24. 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.

    Time frame: 2 months

  25. 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.

    Time frame: 6 months

  26. 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.

    Time frame: 12 months

Other outcomes

  1. Patient activity

    Patient activity measured with triaxial wrist accelerometer

    Time frame: 4 weeks

07

Study locations

5 sites
  • Teemu Karjalainen
    Jyväskylä, Finland
  • Kuopio University Hospital
    Kuopio, Finland
  • Laura Kärnä
    Tampere, Finland
  • Danderyds Sjukhus
    Danderyd, Sweden
  • Sundsvalls sjukhuset
    Sundsvall, Sweden
08

References and documents

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 documents

  • Statistical analysis plan · Nov 20, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Data is available on reasonable request.

Supporting information: Study protocol, Sap, Icf, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05150925
Lead sponsor
Tampere University Hospital
Collaborators
Kuopio University Hospital, Jyväskylä Central Hospital, Sundsvall Hospital, Danderyd Hospital
Responsible party
Aleksi Reito (Associate professor, Tampere University Hospital) — Principal investigator
First posted
Dec 9, 2021
Start date
Dec 1, 2021
Primary completion
Feb 10, 2026
Completion
Feb 10, 2027 (estimated)
Last update
Feb 11, 2026

Study contacts

Aleksi Reito
study director · Tampere University Hospital
Laura Kärnä, MD
principal investigator · Tampere University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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