Flexor Tendon Injury Clinical Trial
Official title:
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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| Completed |
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| Terminated |
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N/A |