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GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis

NCT01724840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-08-22

No results posted yet for this study

Summary

Studies at the shoulder, Achilles tendon and thumb show satisfactory results regarding the use of GaftJacket. Initial trials at the thumb show, that the GraftJacket can be safely and successfully used in TMC OA surgery and therefore represents an acceptable alternative for avoiding possible donor-site morbidity. However, there are no randomised controlled trials (RCT) in which the outcomes of using a tendon interposition or the GraftJacket are compared. Only with an RCT design it is possible to gain evidence about the advantages of one treatment method over another. The main objective of the study is the comparison between two surgical techniques for TMC OA: The resection interposition suspension arthroplasty using a part of the flexor carpi radialis tendon as interpositional material and using the GraftJacket as interpositional material.

Conditions

  • Osteoarthrosis of the Carpometacarpal Joint of the Thumb

Interventions

PROCEDURE

GraftJacket

Interposition with GraftJacket

PROCEDURE

Tendon Interposition

Tendon Interposition with the FCR tendon

Sponsors & Collaborators

  • Schulthess Klinik

    lead OTHER

Principal Investigators

  • Daniel B Herren, MD, MHA · Schulthess Klinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Switzerland

Study Locations

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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 NCT01724840 on ClinicalTrials.gov