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Amniotic Membrane Wrapping and Tenolysis Versus Tenolysis Alone for Treatment of Tendon Adhesions of the Hand/Wrist

NCT03013582 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-01-06

No results posted yet for this study

Summary

Tendon adhesions of the hand remain a ubiquitous problem facing hand surgeons and hand therapists alike. Despite their commonality, no consensus exists as to the best means of preventing adhesions, or the most ideal methods to treat them once they have occurred. The purpose of this study is to compare patient outcomes after standard operative tenolysis performed for adhesions of the hand to outcomes after tenolysis with the use of allograft human amniotic membrane.

Conditions

  • Tendinopathy
  • Adhesions Nos Postoperative
  • Scar
  • Fibrosis

Interventions

BIOLOGICAL

Amnion Tendon Wrapping

Tendon is wrapped with the allograft

PROCEDURE

Surgical Tenolysis

Surgical release of peritendinous scarred tissue

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Randall W Culp, MD · Thomas Jefferson University-Philadelphia Hand Center

  • Michael P Gaspar, MD · Thomas Jefferson University-Philadelphia Hand Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-07-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03013582 on ClinicalTrials.gov