Study of the Repair of Flexor Tendons of the Hand

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962490
• Other study ID #: IIBSP-TFM-2021-34
• Status: Recruiting
• Start date: July 23, 2021
• Est. completion date: December 16, 2024

Study information

• Verified date: March 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Claudia Lamas, MD. Ph D
• Phone: 935537032
• Email: clamasg[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 16, 2024
• Est. primary completion date: July 15, 2024
• 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.

Related Conditions & MeSH terms

• Tendon Injuries
• Tendon Injury - Hand

Intervention

Procedure:
• Repair: 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.

Locations

Country	Name	City	State
Spain	Claudia Erika Delgado Espinoza	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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

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

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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

Outcome

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