LIMPER-DRF: Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Study Details
Study Description
Brief Summary
The aim of this study is to analyze return to work and functional outcome at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 return to work and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Study Design
Arms and Interventions
| 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
|
Other: Cast treatment
Dorsal cast placed in OR
Procedure: Volar plating
Volar plating of distal radius fracture
|
Outcome Measures
Primary Outcome Measures
- Patient-rated wrist evaluation questionnaire [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.
- Return to work [2 months]
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.
Secondary Outcome Measures
- Patient-rated wrist evaluation questionnaire [4 weeks]
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 [6 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.
- Patient-rated wrist evaluation questionnaire [12 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.
- Return to work [4 weeks]
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 [6 months]
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 [12 months]
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.
- Overall sick leave [12 months]
Total number of days of work during the 1 year study period
- Complications [4 weeks]
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
- Complications [2 months]
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
- Complications [6 months]
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome
- Complications [12 months]
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 [4 weeks]
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 [2 months]
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 [6 months]
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 [12 months]
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 [4 weeks]
Overall pain during last 7 days in a scale from 0 to 100 (worst)
- Visual analogue pain scale [2 months]
Overall pain during last 7 days in a scale from 0 to 100 (worst)
- Visual analogue pain scale [6 months]
Overall pain during last 7 days in a scale from 0 to 100 (worst)
- Visual analogue pain scale [12 months]
Overall pain during last 7 days in a scale from 0 to 100 (worst)
Other Outcome Measures
- Patient activity [4 weeks]
Patient activity measured with triaxial wrist accelerometer
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Teemu Karjalainen | Jyväskylä | Finland | ||
| 2 | Laura Kärnä | Tampere | Finland |
Sponsors and Collaborators
- Tampere University Hospital
Investigators
- Study Director: Aleksi Reito, Tampere University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R21111