Percutaneous Pinning vs Orthosis and Early Mobilization
- Conditions
- Finger FractureHand Injuries
- Interventions
- Procedure: Percutaneous pinningProcedure: Conservative treatment
- Registration Number
- NCT04561661
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
-Fractures of the base phalanx of digit 2-5 in the hand.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery Percutaneous pinning Fractures treated with closed reduction, percutaneous pinning (k-wires) and plaster. Conservative treatment Conservative treatment Fracture treated with closed reduction, custom made orthosis and early mobilization.
- Primary Outcome Measures
Name Time Method TAM (Total active range of motion) 3 years Total active range of motion measured in degrees of the affected finger.
- Secondary Outcome Measures
Name Time Method Patient related outcome measure DASH 3, 6 months and 1 and 3 years Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.
Patient related outcome measure EQ-5D 3, 6 months and 1 and 3 years 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).
Patient related outcome measure HQ-8 3, 6 months and 1 and 3 years 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.
Grips strength 3, 6 months and 1 and 3 years Measured in kilograms (JAMAR)
Patient related outcome measure HADS 3, 6 months and 1 and 3 years 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.
Number of sick days 3 months Number of sick days from the intervention until full return to work.
Trial Locations
- Locations (1)
Dept Hand Surgery
🇸🇪Stockholm, Sweden