Dept Hand Surgery
Stockholm, Sweden
Location status: Recruiting
NCT Number: NCT04561661
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Fractures of the base phalanx of digit 2-5 in the hand.
Exclusion criteria
Closed reduction, percutaneous pinning and plaster
Closed reduction, custom made orthosis and early mobilization
Time frame: 3 months
Total active range of motion measured in degrees of the affected finger.
Time frame: 6 months
Total active range of motion measured in degrees of the affected finger.
Time frame: 1 year
Total active range of motion measured in degrees of the affected finger.
Time frame: 3 years
Total active range of motion measured in degrees of the affected finger.
Time frame: 3 months
Number of sick days from the intervention until full return to work.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 3, 6 months and 1 and 3 years
Measured in kilograms (JAMAR)
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
A Randomized Comparison Between Percutaneous Pinning and Non-surgical Management of Proximal Phalangeal Fractures
Acronym: POEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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