Clinical Trials Directory

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

TypeNameDescription
PROCEDUREPercutaneous pinningClosed reduction, percutaneous pinning and plaster
PROCEDUREConservative treatmentClosed 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.