Tendon Injury - Hand Clinical Trial
Official title:
Study of the Repair of Flexor Tendons of the Hand: Epidemiological and Prognostic Factors Associated With Tendon Injuries in Zone II
Injury to the flexor tendons of the fingers of the hand is a frequent and disabling injury, since it produces tendon retraction and functional limitation. A prompt and adequate diagnosis and treatment is required to minimize the risk of tendon retraction, re-rupture, reoperation rate, and the presence of tendon adhesions that limit the range of motion. On occasions, the limitation of the articular balance of the MCP, PIP and DIP joints generates a loss of strength and difficult in completely closing the fingers to the palm of the hand.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 16, 2024 |
Est. primary completion date | July 15, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients with section of the superficial and / or profundus flexor tendons in the hand. - Patients with section of the flexor tendon in the thumb - Tendon injury in any anatomical area - In the acute, subacute or chronic phases of the disease - Associated or not with fractures - Associated or not with arterial or nerve injuries Exclusion Criteria: - Previous bone disease - History of tendon injury to the extensor or flexor tendons - Joint stiffness prior to tendon section - Rheumatic arthropathy - History of operations in the same area. |
Country | Name | City | State |
---|---|---|---|
Spain | Claudia Erika Delgado Espinoza | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Spain,
Amadio PC, Hunter JM, Jaeger SH, Wehbe MA, Schneider LH. The effect of vincular injury on the results of flexor tendon surgery in zone 2. J Hand Surg Am. 1985 Sep;10(5):626-32. doi: 10.1016/s0363-5023(85)80197-0. — View Citation
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Moriya K, Yoshizu T, Tsubokawa N, Narisawa H, Matsuzawa S, Maki Y. Outcomes of flexor tendon repairs in zone 2 subzones with early active mobilization. J Hand Surg Eur Vol. 2017 Nov;42(9):896-902. doi: 10.1177/1753193417715213. Epub 2017 Jun 13. — View Citation
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Tang JB. Indications, methods, postoperative motion and outcome evaluation of primary flexor tendon repairs in Zone 2. J Hand Surg Eur Vol. 2007 Apr;32(2):118-29. doi: 10.1016/J.JHSB.2006.12.009. Epub 2007 Feb 12. — View Citation
Tang JB. Outcomes and evaluation of flexor tendon repair. Hand Clin. 2013 May;29(2):251-9. doi: 10.1016/j.hcl.2013.02.007. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of motion (ROM) | Change in the mobility of the MCP, PIP and DIP joints. Evaluation with goniometer (cm) | 12 months | |
Primary | Grip Strength | Change of strength with respect to the contralateral hand. Evaluation with Jamar Dinamometer (Kg) | 12 months | |
Primary | Chronic residual pain | Evaluation residual pain at rest and with activity with the Visual Analogue Scale (values from 0 to 10; 0 is the better outcome and 10 is the worse outcome). | 12 months | |
Secondary | Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.). | Evaluacion of epidemiological factors associated with outcomes in flexor injuries. | 12 months | |
Secondary | Trauma variables | Affected finger, dominant hand, involvement of one or more fingers, type of injury (complete / partial section / association with fractures /association with arterial injury/ association with nerve injury/ section only FP or section FS plus FP). | 12 months |
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