Clinical trial NCT04561661: Percutaneous Pinning vs Orthosis and Early Mobilization
Official title: A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Injuries
Finger Fracture
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: TAM (Total active range of motion)
timeFrame: 3 months
measure: TAM (Total active range of motion)
timeFrame: 6 months
measure: TAM (Total active range of motion)
timeFrame: 1 year
measure: TAM (Total active range of motion)
timeFrame: 3 years
Secondary outcomes:
measure: Number of sick days
timeFrame: 3 months
measure: Patient related outcome measure DASH
timeFrame: 3, 6 months and 1 and 3 years
measure: Patient related outcome measure HADS
timeFrame: 3, 6 months and 1 and 3 years
measure: Patient related outcome measure EQ-5D
timeFrame: 3, 6 months and 1 and 3 years
measure: Patient related outcome measure HQ-8
timeFrame: 3, 6 months and 1 and 3 years
measure: Grips strength
timeFrame: 3, 6 months and 1 and 3 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept Hand Surgery
Study officials:
affiliation: Karolinska Institutet
name: Johanna von Kieseritzky, MD PhD
role: STUDY_DIRECTOR
References: