Study of the Repair of Flexor Tendons of the Hand

Recruiting

• Conditions: Tendon Injury - Hand

• Registration Number: NCT04962490
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

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.

Detailed Description

To retrospectively evaluate the results obtained with the suture/ reinsertion of the flexor tendons of the hand, in the acute, subacute and chronic phases, treated surgically in our center between the years 2000 and 2021.

To evaluate the clinical and functional results obtained in patients who underwent surgery for a section of the flexor tendons, superficial, profundus or both, preferably in zone II of the hand. The investigators evaluate the epidemiological and prognostic factors associated with the injury, in the different phases and anatomical zones.

The researchers evaluate the functional results:

Pain at rest with movements: Assessed using the visual analogue pain scale (VAS Scale from 0 to 10).

Joint balance / Range of motion of the MCP, PIP, DIP joints. Evaluation by digital goniometer. Evaluation using Buck-Gramcko (1976) and using the Tang (2007) criteria.

Grip strength. Evaluation using a Jamar dynamometer. Functional rating scales: QuickDASH Score Reoperation rate: 1) For re-rupture / re-suture, 2) For infection, 3) For excision of tendon adhesions: arthrolysis and tendolysis, 4) For tendon transfer 5) For tendon graft placement.

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-15
• Study Start: 2021-07-23
• Status Verified: 2023-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2024-07-15
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Range of motion (ROM)	12 months	Change in the mobility of the MCP, PIP and DIP joints. Evaluation with goniometer (cm)
Grip Strength	12 months	Change of strength with respect to the contralateral hand. Evaluation with Jamar Dinamometer (Kg)
Chronic residual pain	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.).	12 months	Evaluacion of epidemiological factors associated with outcomes in flexor injuries.
Trauma variables	12 months	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).

Trial Locations

Locations (1)

Claudia Erika Delgado Espinoza; 🇪🇸 Barcelona, Spain