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Study of the Repair of Flexor Tendons of the Hand

Study of the Repair of Flexor Tendons of the Hand: Epidemiological and Prognostic Factors Associated With Tendon Injuries in Zone II

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04962490
Enrollment
100
Registered
2021-07-15
Start date
2021-07-23
Completion date
2024-12-16
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon Injury - Hand

Keywords

tendon, flexor, hand

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.

Interventions

PROCEDURERepair: suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich)

Repair tendon flexor sections in the hand: Suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich). The surgery depends on the anatomical area of the tendon section and the time between the injury and the operation.

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Range of motion (ROM)12 monthsChange in the mobility of the MCP, PIP and DIP joints. Evaluation with goniometer (cm)
Grip Strength12 monthsChange of strength with respect to the contralateral hand. Evaluation with Jamar Dinamometer (Kg)
Chronic residual pain12 monthsEvaluation 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

MeasureTime frameDescription
Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.).12 monthsEvaluacion of epidemiological factors associated with outcomes in flexor injuries.
Trauma variables12 monthsAffected 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).

Countries

Spain

Contacts

Primary ContactClaudia Lamas, MD. Ph D
clamasg@santpau.cat935537032
Backup ContactClaudia Lamas, MD, Ph D
clamasg@santpau.cat935537032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026