Percutaneous Pinning vs Orthosis and Early Mobilization (POEM)

Karolinska Institute

Status: Enrolling

Conditions: Finger Fracture; Hand Injuries

Treatments: Procedure: Conservative treatment; Procedure: Percutaneous pinning

Study type: Interventional

Funder types: Other

Identifiers

NCT04561661

Frakturstudien

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Fractures of the base phalanx of digit 2-5 in the hand.

Exclusion criteria

• Fracture older than 2 weeks.
• More than 25° of sagittal plane and/or 10° lateral angulation after reposition.
• Intra-articular step >1mm.
• Associated fractures in other bones (i e metacarpals, middle and distal phalanges) and/or tendon and nerve injuries in any finger.
• Open fractures.
• Patient age <18 years.
• Inability to co-operate with the follow-up protocol (i.e. language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Conservative treatment

Active Comparator group

Description:

Fracture treated with closed reduction, custom made orthosis and early mobilization.

Treatment:

Procedure: Conservative treatment

Surgery

Active Comparator group

Description:

Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.

Treatment:

Procedure: Percutaneous pinning