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

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ClinicalTrials.gov Identifier: NCT02361814
Recruitment Status : Terminated (Unfavorable results)
First Posted : February 12, 2015
Last Update Posted : June 27, 2017
Sponsor:
Collaborators:
Tampere University Hospital
Central Finland Hospital District
Information provided by (Responsible Party):
Olli Leppänen, University of Tampere

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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
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 : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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.




Primary Outcome Measures :
  1. Total range of movement of the injured finger [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Total range of movement of the injured finger [ Time Frame: 2, 4, and 8 weeks ]
  2. Rupture of the repair [ Time Frame: 2, 4, 8 weeks, and 6 months ]
  3. Postoperative infection [ Time Frame: 2, 4, 8 weeks, and 6 months ]
  4. QuickDASH -score [ Time Frame: 2, 4, 8 weeks, and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361814


Locations
Finland
University of Tampere
Tampere, Finland
Sponsors and Collaborators
University of Tampere
Tampere University Hospital
Central Finland Hospital District
Investigators
Study Chair: Harry Göransson, M.D., Ph.D. Tampere University Hospital

Responsible Party: Olli Leppänen, Researcher, University of Tampere
ClinicalTrials.gov Identifier: NCT02361814     History of Changes
Other Study ID Numbers: R15002
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Olli Leppänen, University of Tampere:
flexor tendon
finger
amniotic membrane
allograft
tendon injury

Additional relevant MeSH terms:
Tendon Injuries
Wounds and Injuries