Repair Of Flexor Tendon In Zone II Using Minimal Incisions

NCT05809102 | Completed

• 1 other identifier: Minimal Incisions in Zone II
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Repair of the zone II flexor tendon of the hand using minimal incisions is successful with good results which will improve the outcome of the repair.

Conditions

Flexor Tendon Rupture

Outcome Measures

Primary Outcomes (1)

• range of motions

  range of motions of fingers using Jamar finger goniometer

  end point 6 months post-operative

Secondary Outcomes (3)

• complications

  end point 6 months post-operative

• Healing vs failure of repair

  baseline

• DASH score using DASH questionnaire

  6 months

Study Arms (1)

Minimal incisions

OTHER

Repair of Zone II using minimal incisions

Procedure: repair of flexor tendon in Zone II

Interventions

repair of flexor tendon in Zone II PROCEDURE

Repair of Zone II flexor tendon of the hand using minimal incisions instead of whole tendon exposure

Minimal incisions

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: between 16-60 years.
• Flexor tendon injuries of zone II of any medial four digits in both genders.
• within two weeks.
• Sharp mechanism of injury.
• Single-level injury
• Minimal surgical incision.

You may not qualify if:

• Age less than sixteen years old or more than sixty years old.
• Amputation requiring replantation.
• Vascular injury requiring revascularization
• Associated fractures close to the tendon injury.
• Combined flexor and extensor tendon injury.
• Multiple-level injury
• Tendon substance loss
• Insufficient skin and soft tissue coverage.
• Surgical incision for whole tendon exposure.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (3)

• Griffin M, Hindocha S, Jordan D, Saleh M, Khan W. An overview of the management of flexor tendon injuries. Open Orthop J. 2012;6:28-35. doi: 10.2174/1874325001206010028. Epub 2012 Feb 23.

  PMID: 22431948 BACKGROUND

• Kotwal PP, Ansari MT. Zone 2 flexor tendon injuries: Venturing into the no man's land. Indian J Orthop. 2012 Nov;46(6):608-15. doi: 10.4103/0019-5413.104183.

  PMID: 23325961 BACKGROUND

• Schoffl V, Heid A, Kupper T. Tendon injuries of the hand. World J Orthop. 2012 Jun 18;3(6):62-9. doi: 10.5312/wjo.v3.i6.62.

  PMID: 22720265 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assitant lecturer

Model Details: Minimal incisions in repair of Zone II flexor tendon of the hand instead of whole exposure of the tendon

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: April 12, 2023
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 30, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

EG (1)