Using Human Amniotic Membrane to Improve Flexor Tendon Repair in the Hand: A Clinical Trial

Investigation of the Outcomes of Using Human Amniotic Membrane in Flexor Tendon Repair in Zones IV and V of the Hand Compared to Classical Flexor Tendon Repair: A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250907067151N1

Enrollment

Registered

2025-11-04

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flexor tendon injury. Spontaneous rupture of flexor tendons, unspecified hand

Interventions

Intervention 1: Intervention group: Patients with complete flexor tendon rupture in either zone IV or V of one hand will undergo tendon repair, with the repair site augmented by wrapping it with a hum

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Complete flexor tendon rupture in either zone IV or zone V Time interval between injury and surgery less than 24 hours Possibility of direct skin closure at the injury site Willingness to participate in the study Age between 18 and 65 years

Exclusion criteria

Exclusion criteria: Recurrent tendon rupture Hereditary connective tissue disorders Thumb injuries Vascular injury requiring repair Concomitant phalanx fracture requiring immobilization Diabetes malignancy coagulation disorders psychiatric disorders Tobacco use Failure to follow-up for treatment Non-adherence to prescribed physiotherapy

Design outcomes

Primary

Measure	Time frame
Active flexion. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: buck gramcko score.;Pinch test. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: dynamometer.;Handgrip. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: dynamometer.;QuickDASH questionnaire. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Standardized Persian QuickDASH questionnaire.;Pain. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Visual Analogue Scale.	—

Measure

Time frame

Active flexion. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: buck gramcko score.;Pinch test. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: dynamometer.;Handgrip. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: dynamometer.;QuickDASH questionnaire. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Standardized Persian QuickDASH questionnaire.;Pain. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Visual Analogue Scale.

—

Secondary

Measure	Time frame
Infection. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Physical examination.;Hypersensitivity. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Physical examination.;Return to activity. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Question.;Need for reoperation. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Clinical follow up and patient records.	—

Measure

Time frame

Infection. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Physical examination.;Hypersensitivity. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Physical examination.;Return to activity. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Question.;Need for reoperation. Timepoint: 1, 2, 3, 6, and 12 months postoperatively. Method of measurement: Clinical follow up and patient records.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSajad Heshmatifar

Shahid Beheshti University of Medical Sciences

sajjad.heshmati1990@gmail.com+98 21 4611 8649

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026