Hand Injuries, Finger Fracture
Conditions
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.
Interventions
PROCEDUREPercutaneous pinning
Closed reduction, percutaneous pinning and plaster
PROCEDUREConservative treatment
Closed reduction, custom made orthosis and early mobilization
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TAM (Total active range of motion) | 3 months | Total active range of motion measured in degrees of the affected finger. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of sick days | 3 months | Number of sick days from the intervention until full return to work. |
| 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. |
| Grips strength | 3, 6 months and 1 and 3 years | Measured in kilograms (JAMAR) |
| 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. |
| 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. |
Countries
Sweden
Contacts
Primary ContactHenrik Alfort, MD
Outcome results
None listed