Clinical trial NCT04962490: Study of the Repair of Flexor Tendons of the Hand
Official title: Study of the Repair of Flexor Tendons of the Hand: Epidemiological and Prognostic Factors Associated With Tendon Injuries in Zone II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tendon Injury - Hand
Keywords: tendon, flexor, hand
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Range of motion (ROM)
timeFrame: 12 months
measure: Grip Strength
timeFrame: 12 months
measure: Chronic residual pain
timeFrame: 12 months
Secondary outcomes:
measure: Epidemiological variables age, sex, smoker, diabetes, heart disease, other diseases (lung, kidney, etc.).
timeFrame: 12 months
measure: Trauma variables
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Claudia Erika Delgado Espinoza
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Claudia Lamas, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Manske PR. Flexor tendon healing. J Hand Surg Br. 1988 Aug;13(3):237-45. doi: 10.1016/0266-7681_88_90077-0.
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.
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.
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.
citation: 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.
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.
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.
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.
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.