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Percutaneous Pinning vs Orthosis and Early Mobilization

Not Applicable
Recruiting
Conditions
Finger Fracture
Hand Injuries
Interventions
Procedure: Percutaneous pinning
Procedure: 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
Inclusion Criteria

-Fractures of the base phalanx of digit 2-5 in the hand.

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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SurgeryPercutaneous pinningFractures treated with closed reduction, percutaneous pinning (k-wires) and plaster.
Conservative treatmentConservative treatmentFracture treated with closed reduction, custom made orthosis and early mobilization.
Primary Outcome Measures
NameTimeMethod
TAM (Total active range of motion)3 years

Total active range of motion measured in degrees of the affected finger.

Secondary Outcome Measures
NameTimeMethod
Patient related outcome measure DASH3, 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-5D3, 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-83, 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 strength3, 6 months and 1 and 3 years

Measured in kilograms (JAMAR)

Patient related outcome measure HADS3, 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 days3 months

Number of sick days from the intervention until full return to work.

Trial Locations

Locations (1)

Dept Hand Surgery

🇸🇪

Stockholm, Sweden

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