Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate (LIMPER-DRF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Other: Immediate mobilization; Procedure: Volar plating; Other: Cast treatment

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 Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Jyväskylä, Finland
    • Teemu Karjalainen
  • Kuopio, Finland
    • Kuopio University Hospital
  • Tampere, Finland
    • Laura Kärnä
• Sweden
  • Danderyd, Sweden
    • Danderyds sjukhus
  • Sundsvall, Sweden
    • Sundsvalls sjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate mobilization after distal radius fracture treated with volar locking plate	Other: Immediate mobilization; Immediate mobilization postoperatively without casting; Procedure: Volar plating; Volar plating of distal radius fracture
Active Comparator: 2 weeks cast immobilization after distal radius fracture treated with volar locking plate	Procedure: Volar plating; Volar plating of distal radius fracture; Other: Cast treatment; Dorsal cast placed in OR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months
Total lenght of the sick leave	Total number of days of work during the 1 year study period	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	12 months
Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	4 weeks
Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	2 months
Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	6 months
Complications	Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome	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).	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).	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).	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).	12 months
Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	4 weeks
Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	2 months
Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	6 months
Visual analogue pain scale	Overall pain during last 7 days in a scale from 0 to 100 (worst)	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)?	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)?	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)?	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.	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.	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.	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient activity	Patient activity measured with triaxial wrist accelerometer	4 weeks

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Kuopio University Hospital; Sundsvall Hospital; Danderyd Hospital; Jyväskylä Central Hospital
• Investigators: Study Director: Aleksi Reito, Tampere University Hospital; Principal Investigator: Laura Kärnä, MD, Tampere University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): February 10, 2026
• Study Completion (Estimated): February 10, 2027

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: surgery; distal radius fracture; volar plating
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Wrist Fractures
• Other Study ID Numbers: R21111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data is available on reasonable request.
• IPD Sharing Time Frame: After the study has been completed and for 10 years after.
• IPD Sharing Access Criteria: On reasonable request and research plan for IPD use should be provided.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No