Percutaneous Pinning vs Orthosis and Early Mobilization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hand Injuries, Finger Fracture

Intervention / Treatment
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* Procedure: Percutaneous pinning
* Procedure: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled clinical trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |