Trials / Recruiting
RecruitingNCT04561661
Percutaneous Pinning vs Orthosis and Early Mobilization
A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Karolinska Institutet · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims at investigating if splinting and early mobilization is a better method, regarding range of motion, for treating fractures of the base phalanx of the fingers compared to surgery with pinning. This will be achieved through a randomised clinical trial comparing the two methods.
Detailed description
Proximal phalangeal fractures of the hand are very common and affect patients of all ages. . Most fractures heal without complications but these injuries can result in impaired hand function and prolonged inability to work and perform activities of daily living. If there is a dislocation that cannot easily be repositioned to a stable position, surgery might be required. Surgery is often performed with percutaneous pinning and immobilisation in plaster for 4 weeks. Good results of non-surgical treatment with a splint that allows immediate mobilization of the interphalangeal joints has been reported. This study will compare these two methods for treating fractures of the base phalanx of the fingers. Recruited patients will be randomized to one of the two treatment arms: 1. surgery with pinning 2. conservative treatment with a splint. Primary outcome is total active range of motion in the affected finger at 3, 6 months and 1 , 3 years. Secondary outcomes are number of sick days and various patient related outcome measures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Percutaneous pinning | Closed reduction, percutaneous pinning and plaster |
| PROCEDURE | Conservative treatment | Closed reduction, custom made orthosis and early mobilization |
Timeline
- Start date
- 2021-03-03
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2020-09-23
- Last updated
- 2025-06-03
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT04561661. Inclusion in this directory is not an endorsement.