Percutaneous Pinning vs Orthosis and Early Mobilization

NCT04561661 | Recruiting

• 1 other identifier: Frakturstudien
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Injuries; Finger Fracture

Outcome Measures

Primary Outcomes (4)

• TAM (Total active range of motion)

  Total active range of motion measured in degrees of the affected finger.

  3 months

• TAM (Total active range of motion)

  Total active range of motion measured in degrees of the affected finger.

  6 months

• TAM (Total active range of motion)

  Total active range of motion measured in degrees of the affected finger.

  1 year

• TAM (Total active range of motion)

  Total active range of motion measured in degrees of the affected finger.

  3 years

Secondary Outcomes (6)

• Number of sick days

  3 months

• Patient related outcome measure DASH

  3, 6 months and 1 and 3 years

• Patient related outcome measure HADS

  3, 6 months and 1 and 3 years

• Patient related outcome measure EQ-5D

  3, 6 months and 1 and 3 years

• Patient related outcome measure HQ-8

  3, 6 months and 1 and 3 years

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

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

Procedure: Conservative treatment

Surgery

ACTIVE COMPARATOR

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

Procedure: Percutaneous pinning

Interventions

Percutaneous pinning PROCEDURE

Closed reduction, percutaneous pinning and plaster

Surgery

Conservative treatment PROCEDURE

Closed reduction, custom made orthosis and early mobilization

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Dept Hand Surgery

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Hand Injuries

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Johanna von Kieseritzky, MD PhD

  Karolinska Institutet

  STUDY DIRECTOR

Central Study Contacts

Henrik Alfort, MD

CONTACT

+46704044648; henrik.alfort@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd, Associate prof

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 23, 2020
• Study Start: March 3, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)