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

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.

Study Overview

• Status: Recruiting
• Conditions: Tendon Injury - Hand
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Claudia Lamas, MD, Ph D; Phone Number: 935537032; Email: clamasg@santpau.cat
• Study Contact Backup: Name: Claudia Lamas, MD. Ph D; Phone Number: 935537032; Email: clamasg@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Claudia Erika Delgado Espinoza
    • Contact: Claudia Erika Delgado Espinoza, MD, Ph D; Phone Number: 935537634; Email: CDelgadoE@santpau.cat
    • Contact: Claudia Erika Delgado Espinoza, MD, Ph D; Email: CDelgadoE@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• Manske PR. Flexor tendon healing. J Hand Surg Br. 1988 Aug;13(3):237-45. doi: 10.1016/0266-7681_88_90077-0.
• 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.
• 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.
• 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.
• 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.
• 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.
• Buck-Gramcko D, Dietrich FE, Gogge S. [Evaluation criteria in follow-up studies of flexor tendon therapy]. Handchirurgie. 1976;8(2):65-9. German.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: tendon, flexor, hand
• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: IIBSP-TFM-2021-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No