Percutaneous Pinning vs Orthosis and Early Mobilization

Hand Injuries Clinical Trial

— POEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561661
• Other study ID #: Frakturstudien
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Henrik Alfort, MD
• Phone: +46704044648
• Email: henrik.alfort[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Finger Fracture
• Hand Injuries

Intervention

Procedure:
• Percutaneous pinning
Closed reduction, percutaneous pinning and plaster
• Conservative treatment
Closed reduction, custom made orthosis and early mobilization

Locations

Country	Name	City	State
Sweden	Dept Hand Surgery	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TAM (Total active range of motion)	Total active range of motion measured in degrees of the affected finger.	3 months
Primary	TAM (Total active range of motion)	Total active range of motion measured in degrees of the affected finger.	6 months
Primary	TAM (Total active range of motion)	Total active range of motion measured in degrees of the affected finger.	1 year
Primary	TAM (Total active range of motion)	Total active range of motion measured in degrees of the affected finger.	3 years
Secondary	Number of sick days	Number of sick days from the intervention until full return to work.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Grips strength	Measured in kilograms (JAMAR)	3, 6 months and 1 and 3 years