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

Primary Purpose

Distal Radius Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Cast treatment
Immediate mobilization
Volar plating
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring distal radius fracture, volar plating, surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teemu KarjalainenRecruiting
  • Laura KärnäRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate mobilization after distal radius fracture treated with volar locking plate

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

Arm Description

Outcomes

Primary Outcome Measures

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.
Total lenght of the sick leave
Total number of days of work during the 1 year study period

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
Complications
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
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).
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).
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).
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).
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Visual analogue pain scale
Overall pain during last 7 days in a scale from 0 to 100 (worst)
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)?
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)?
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)?
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.
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.
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.
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.

Full Information

First Posted
October 7, 2021
Last Updated
September 30, 2022
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05150925
Brief Title
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Acronym
LIMPER-DRF
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
distal radius fracture, volar plating, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate mobilization after distal radius fracture treated with volar locking plate
Arm Type
Experimental
Arm Title
2 weeks cast immobilization after distal radius fracture treated with volar locking plate
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cast treatment
Intervention Description
Dorsal cast placed in OR
Intervention Type
Other
Intervention Name(s)
Immediate mobilization
Intervention Description
Immediate mobilization postoperatively without casting
Intervention Type
Procedure
Intervention Name(s)
Volar plating
Intervention Description
Volar plating of distal radius fracture
Primary Outcome Measure Information:
Title
Patient-rated wrist evaluation questionnaire
Description
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
Title
Total lenght of the sick leave
Description
Total number of days of work during the 1 year study period
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patient-rated wrist evaluation questionnaire
Description
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
Title
Patient-rated wrist evaluation questionnaire
Description
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
Title
Patient-rated wrist evaluation questionnaire
Description
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
Title
Return to work
Description
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
Title
Return to work
Description
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
Title
Return to work
Description
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
Title
Return to work
Description
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
Title
Complications
Description
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
Title
Complications
Description
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
Title
Complications
Description
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
Title
Complications
Description
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
Title
Self-perceived working ability
Description
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
Title
Self-perceived working ability
Description
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
Title
Self-perceived working ability
Description
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
Title
Self-perceived working ability
Description
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
Title
Visual analogue pain scale
Description
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Time Frame
4 weeks
Title
Visual analogue pain scale
Description
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Time Frame
2 months
Title
Visual analogue pain scale
Description
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Time Frame
6 months
Title
Visual analogue pain scale
Description
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Time Frame
12 months
Title
Patient-acceptable symptom state
Description
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
Title
Patient-acceptable symptom state
Description
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
Title
Patient-acceptable symptom state
Description
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
Title
Work capacity
Description
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
Title
Work capacity
Description
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
Title
Work capacity
Description
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
Title
Work capacity
Description
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 Pre-specified Outcome Measures:
Title
Patient activity
Description
Patient activity measured with triaxial wrist accelerometer
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Kärnä, MD
Phone
+3583311611
Email
laura.karna@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Antti Launonen
Phone
+3583311611
Email
antti.launonen@pshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksi Reito
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Teemu Karjalainen
City
Jyväskylä
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ville Ponkilainen
First Name & Middle Initial & Last Name & Degree
Toni Luokkala
Facility Name
Laura Kärnä
City
Tampere
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Kärnä
Phone
+3583311611
First Name & Middle Initial & Last Name & Degree
Reito
First Name & Middle Initial & Last Name & Degree
Launonen

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
36368761
Citation
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.
Results Reference
derived

Learn more about this trial

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

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