Study of the Repair of Flexor Tendons of the Hand

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Recruiting
CT.gov ID
NCT04962490
Collaborator
(none)
100
1
17.3
5.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Repair: suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich)

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Study of the Repair of Flexor Tendons of the Hand: Epidemiological and Prognostic Factors Associated With Tendon Injuries in Zone II
Actual Study Start Date :
Jul 23, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Range of motion (ROM) [12 months]

    Change in the mobility of the MCP, PIP and DIP joints. Evaluation with goniometer (cm)

  2. Grip Strength [12 months]

    Change of strength with respect to the contralateral hand. Evaluation with Jamar Dinamometer (Kg)

  3. 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

  1. 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.

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Claudia Erika Delgado Espinoza Barcelona Spain 08025

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Claudia Lamas, MD, Ph D, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT04962490
Other Study ID Numbers:
  • IIBSP-TFM-2021-34
First Posted:
Jul 15, 2021
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2021