Study of the Repair of Flexor Tendons of the Hand

NCT04962490 | Unknown

• 1 other identifier: IIBSP-TFM-2021-34
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendon Injury - Hand

Keywords

tendon, flexor, hand

Outcome Measures

Primary Outcomes (3)

• Range of motion (ROM)

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

  12 months

• Grip Strength

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

  12 months

• 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 Outcomes (2)

• Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.).

  12 months

• Trauma variables

  12 months

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients between 18 and 85 years of age who have suffered a hand injury with section / s of the superficial and / or profundus flexor tendons, or both in hand; and flexor tendon in the thumb.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Claudia Erika Delgado Espinoza

Barcelona, 08025, Spain

RECRUITING

Related Publications (10)

• Doyle JR. Anatomy of the flexor tendon sheath and pulley system: a current review. J Hand Surg Am. 1989 Mar;14(2 Pt 2):349-51. doi: 10.1016/0363-5023(89)90110-x.

  PMID: 2732428 RESULT

• Manske PR. Flexor tendon healing. J Hand Surg Br. 1988 Aug;13(3):237-45. doi: 10.1016/0266-7681_88_90077-0.

  PMID: 3049854 RESULT

• 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.

  PMID: 17298858 RESULT

• Tang JB. Flexor tendon repair in zone 2C. J Hand Surg Br. 1994 Feb;19(1):72-5. doi: 10.1016/0266-7681(94)90054-x.

  PMID: 8169485 RESULT

• 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.

  PMID: 28610452 RESULT

• 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.

  PMID: 4045137 RESULT

• Lundborg G, Myrhage R, Rydevik B. The vascularization of human flexor tendons within the digital synovial sheath region--structureal and functional aspects. J Hand Surg Am. 1977 Nov;2(6):417-27. doi: 10.1016/s0363-5023(77)80022-1.

  PMID: 925330 RESULT

• Buck-Gramcko D, Dietrich FE, Gogge S. [Evaluation criteria in follow-up studies of flexor tendon therapy]. Handchirurgie. 1976;8(2):65-9. German.

  PMID: 992488 RESULT

• 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.

  PMID: 23660061 RESULT

• Strickland JW. Development of flexor tendon surgery: twenty-five years of progress. J Hand Surg Am. 2000 Mar;25(2):214-35. doi: 10.1053/jhsu.2000.jhsu25a0214. No abstract available.

  PMID: 10722813 RESULT

MeSH Terms

Interventions

Replantation; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Transplantation

Study Officials

• Claudia Lamas, MD, Ph D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Lamas, MD. Ph D

CONTACT

935537032; clamasg@santpau.cat

Claudia Lamas, MD, Ph D

CONTACT

935537032; clamasg@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: July 23, 2021
• Primary Completion: July 15, 2024
• Study Completion: December 16, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)