Percutaneous Pinning vs Orthosis and Early Mobilization

NCT ID: NCT04561661

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2026-12-31

Brief 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

Hand Injuries; Finger Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conservative treatment

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

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: PROCEDURE

Closed reduction, custom made orthosis and early mobilization

Surgery

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

Group Type: ACTIVE_COMPARATOR

Percutaneous pinning

Intervention Type: PROCEDURE

Closed reduction, percutaneous pinning and plaster

Interventions

Percutaneous pinning

Closed reduction, percutaneous pinning and plaster

Intervention Type: PROCEDURE

Conservative treatment

Closed reduction, custom made orthosis and early mobilization

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Maria Wilcke

MD, Phd, Associate prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johanna von Kieseritzky, MD PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

Dept Hand Surgery

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Henrik Alfort, MD

Role: CONTACT

henrik.alfort@ki.se

+46704044648

Facility Contacts

Maria Wilcke, MD, PhD

Role: primary

maria.wilcke@ki.se

+4686162022

Other Identifiers

Frakturstudien

Identifier Type: -

Identifier Source: org_study_id