The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair

The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair: a Pilot Study

The objective of this pilot study is to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation after flexor tendon repair.

Study Overview

• Status: Terminated
• Conditions: Flexor Tendon Injury
• Intervention / Treatment: Procedure: The use of amnionic membrane allograft

Detailed Description

The treatment of flexor tendon transection consists of surgical apposition of the lacerated tendon ends using non-absorbable sutures. Main complications which result in poor outcome of the tendon repair are the rupture of the tendon apposition or substantial adhesion formation between the two tendons or the tendon and the fibro-osseous canal. Adhesion formation is presumed to be a byproduct of the tendon healing. In the course of last 70 decades, the preventive effects of several pharmacological agents and mechanical barriers on adhesion formation have been investigated with some promising findings. One of the mechanical barriers that has been proposed to be suitable for adhesion prevention is human amniotic membrane allograft. However, there are no clinical studies evaluating the use of amniotic membrane in flexor tendon repair.

This is a pilot study for the forthcoming randomized controlled study. The objectives of the pilot study are: 1) to test the handleability of the human amniotic membrane allograft in flexor tendon sheath reconstruction in conjunction with flexor tendon repair, 2) to elucidate the possible adverse effects related to the use of amniotic membrane in flexor the sheath, and 3) to gain observational insight into potential preventive features of amniotic membrane transplantation in the adhesion formation. The hypothesis of the pilot study is that the application of the human amniotic membrane allograft in tendon sheath reconstruction in flexor tendon injury patients is technically feasible and results in no adverse effects to the patient.

A total of 10 patients with an acute flexor tendon injury will be included in the pilot study. After conventional tendoraphia, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath. The primary outcome measure is total range of movement after 6 months of the surgery.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • University of Tampere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute flexor tendon transection in zone 2 in digits 2, 3, 4, or 5 (diagnosed within 1 week after the injury)
• Age over 18
• Patient's willingness to participate in the study

Exclusion Criteria:

• Tendon transection within 8 mm of its distal insertion (requiring reinsertion)
• Soft-tissue loss, severe crush, fracture, palmar plate injury, patient requiring revascularization
• Cognitive impairment or other factors (prisoner, military serviceman) which may affect one's decision making
• Substance abuse
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic membrane allograft group; After the conventional flexor tendon repair, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath.	Procedure: The use of amnionic membrane allograft; After the conventional flexor tendon repair, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total range of movement of the injured finger	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total range of movement of the injured finger	2, 4, and 8 weeks
Rupture of the repair	2, 4, 8 weeks, and 6 months
Postoperative infection	2, 4, 8 weeks, and 6 months
QuickDASH -score	2, 4, 8 weeks, and 6 months

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Tampere University Hospital; Central Finland Hospital District
• Investigators: Study Chair: Harry Göransson, M.D., Ph.D., Tampere university Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 25, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: allograft; amniotic membrane; flexor tendon; finger; tendon injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: R15002