Percutaneous Pinning vs Orthosis and Early Mobilization (POEM)

A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures

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.

Study Overview

• Status: Recruiting
• Conditions: Hand Injuries; Finger Fracture
• Intervention / Treatment: Procedure: Conservative treatment; Procedure: Percutaneous pinning

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henrik Alfort, MD; Phone Number: +46704044648; Email: henrik.alfort@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Dept Hand Surgery
    • Contact: Maria Wilcke, MD, PhD; Phone Number: +4686162022; Email: maria.wilcke@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative treatment; Fracture treated with closed reduction, custom made orthosis and early mobilization.	Procedure: Conservative treatment; Closed reduction, custom made orthosis and early mobilization
Active Comparator: Surgery; Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.	Procedure: Percutaneous pinning; Closed reduction, percutaneous pinning and plaster

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sick days	Number of sick days from the intervention until full return to work.	3 months
Patient related outcome measure DASH	Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.	3, 6 months and 1 and 3 years
Patient related outcome measure HADS	Hospital Anxiety and Depression Scale (HADS). The score is consists of one depression scale from 0 to 21, where 0 is no signs of depression and one anxiety scale from 0 to 21, where 0 means no anxiety.	3, 6 months and 1 and 3 years
Patient related outcome measure EQ-5D	EuroQols quality of life index. Consists of an index based on the questionnaire where 0 means death and 1 means full quality of life and one visual analog scale 0-100 where patients rate their health from bad (0) to excellent (100).	3, 6 months and 1 and 3 years
Patient related outcome measure HQ-8	HQ-8 is a questionnaire specifically for hand injuries. Each question gives a score 0-100, where 0 means no problems and 100 means worst imaginable problem.	3, 6 months and 1 and 3 years
Grips strength	Measured in kilograms (JAMAR)	3, 6 months and 1 and 3 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Study Director: Johanna von Kieseritzky, MD PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: Frakturstudien

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No