Clinical trial NCT02361814: The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair
Official title: The Effect of Human Amniotic Membrane Allograft on Functional Recovery After Flexor Tendon Repair: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Flexor Tendon Injury
Keywords: flexor tendon
finger
amniotic membrane
allograft
tendon injury
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Central Finland Hospital District
First posted: 2015-02-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total range of movement of the injured finger
timeFrame: 6 months
Secondary outcomes:
measure: Total range of movement of the injured finger
timeFrame: 2, 4, and 8 weeks
measure: Rupture of the repair
timeFrame: 2, 4, 8 weeks, and 6 months
measure: Postoperative infection
timeFrame: 2, 4, 8 weeks, and 6 months
measure: QuickDASH -score
timeFrame: 2, 4, 8 weeks, and 6 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: University of Tampere
Study officials:
affiliation: Tampere University Hospital
name: Harry Göransson, M.D., Ph.D.
role: STUDY_CHAIR
References: