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

Flexor Tendon Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02361814
• Other study ID #: R15002
• Status: Terminated
• Phase: N/A
• First received: February 3, 2015
• Last updated: June 25, 2017
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: June 2017
• Source: University of Tampere
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon Injury
• Tendon Injuries

Intervention

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.

Locations

Country	Name	City	State
Finland	University of Tampere	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
University of Tampere	Central Finland Hospital District, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total range of movement of the injured finger		6 months
Secondary	Total range of movement of the injured finger		2, 4, and 8 weeks
Secondary	Rupture of the repair		2, 4, 8 weeks, and 6 months
Secondary	Postoperative infection		2, 4, 8 weeks, and 6 months
Secondary	QuickDASH -score		2, 4, 8 weeks, and 6 months