GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724840
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):
Daniel Herren, Schulthess Klinik

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthrosis of the Carpometacarpal Joint of the Thumb Procedure: GraftJacket Procedure: Tendon Interposition Not Applicable

Detailed Description:

Besides the use of the flexor carpi radialis tendon, several materials can serve as the interposition tissue including Gore-Tex, silicone and other types of metal or polymer implants. The use of Gore-Tex, silicone and metal implants, have been shown to carry high complication rates secondary to synovitis and mechanical failure combined with poor patient outcomes. A study about a porcine collagen xenograft was terminated prematurely because of poor outcomes and adverse immunologic reactions.

Another option is using allograft, which is dermal or tendon tissue from another human donor such as the GraftJacket (Wright Medical Technology, Inc., Arlington, TN). This product is manufactured from donated cadaveric tissue that is treated to remove all cellular components while preserving the native collagen scaffold. It thus provides the strength and integrity of native autograft without the adverse immunologic response of traditional allograft. It is in compliance with the American Association of Tissue Banks guidelines for allograft material, and it is classified as human tissue for transplantation.

The GraftJacket shows high biocompatibility and the advantages compared to autograft are avoiding donor site morbidity as well as decreased surgical time.

GraftJacket has mainly being used for the repair of rotator cuff tears and Achilles tendons ruptures. No complications have been reported and patients showed significant improved outcomes compared with their preoperative conditions. Although all of the studies show methodological limitations due to the lack of a control group, these results show a great potential and warrant further investigations.

In contrast to the studies already conducted in the Achilles tendon and shoulder joint, there are only sparse data concerning other joints of the upper extremity such as the elbow and the hand. Treating TMC OA of Eaton stage ll, lll and lV with GraftJacket has only been reported in two studies. The patients under investigation reported significant pain relief, significant improvements regarding grip and key pinch strength, good ability to perform activities of daily living (ADL) and high satisfaction rates. No or only minimal postoperative complications such as paraesthesia which are not directly related to the GraftJacket have been reported. However, some limitations of these two studies have to be acknowledges. Both are observational studies without control group making it impossible to conclude if this approach is favourable compared to standard techniques.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
Study Start Date : September 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: GraftJacket
GraftJAcket is used as interpositional material
Procedure: GraftJacket
Interposition with GraftJacket

Active Comparator: Tendon Interposition
Flexor carpi radialis tendon is used as interpositional material
Procedure: Tendon Interposition
Tendon Interposition with the FCR tendon

Primary Outcome Measures :
  1. Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ]

Secondary Outcome Measures :
  1. Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis. [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ]

Other Outcome Measures:
  1. Costs, Treatment satisfaction, objective and subjective function [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ]

Information from the National Library of Medicine

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

Inclusion criteria:

  • All adult patients diagnosed for TMC OA
  • willing to participate and provide informed consent

Exclusion criteria:

  • Patients with rheumatoid arthritis,
  • pregnant women,
  • legal incompetent patients,
  • persons with insufficient knowledge of the German language to complete the questionnaires

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 identifier (NCT number): NCT01724840

Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Principal Investigator: Daniel B Herren, MD, MHA Schulthess Klinik

Responsible Party: Daniel Herren, MD, MHA, Schulthess Klinik Identifier: NCT01724840     History of Changes
Other Study ID Numbers: GraftJacket01
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases