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

Sponsor

Tampere University (Other)

Overall Status

Terminated

CT.gov ID

NCT02361814

Collaborator

Tampere University Hospital (Other), Central Finland Hospital District (Other)

Enrollment

Location

Arm

18.1

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Flexor Tendon Injury	Procedure: The use of amnionic membrane allograft	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Total range of movement of the injured finger [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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