Percutaneous Pinning vs Orthosis and Early Mobilization
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous pinning
Procedure/SurgeryClosed reduction, percutaneous pinning and plaster
Conservative treatment
Procedure/SurgeryClosed reduction, custom made orthosis and early mobilization
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Conservative treatmentActive comparator 1 intervention
Group B: SurgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Time frame
3 months2
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Time frame
6 months3
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Time frame
1 year4
TAM (Total active range of motion)
Total active range of motion measured in degrees of the affected finger.
Time frame
3 yearsSecondary outcomes
1
Number of sick days
Number of sick days from the intervention until full return to work.
Time frame
3 months2
Patient related outcome measure DASH
Disability of the Arm, Shoulder and Hand score (DASH). 0 points means no disability and 100 maximum disability.
Time frame
3, 6 months and 1 and 3 years3
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.
Time frame
3, 6 months and 1 and 3 years4
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).
Time frame
3, 6 months and 1 and 3 yearsSponsors and contacts
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Source ClinicalTrials.gov