GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Schulthess Klinik
Sponsor:
Information provided by (Responsible Party):
Daniel Herren, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01724840
First received: November 1, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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 Intervention
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Procedure: GraftJacket
Procedure: Tendon Interposition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:
  • Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Costs, Treatment satisfaction, objective and subjective function [ Time Frame: preOP, 6 weeks, 3, 6, and 12months post OP ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724840

Locations
Switzerland
Schulthess Klinik Recruiting
Zurich, Switzerland, 8008
Contact: Miriam Marks, MSc.    0041443857581    marm@kws.ch   
Principal Investigator: Daniel B Herren, MD, MHA         
Sponsors and Collaborators
Schulthess Klinik
Investigators
Principal Investigator: Daniel B Herren, MD, MHA Schulthess Klinik
  More Information

No publications provided

Responsible Party: Daniel Herren, MD, MHA, Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01724840     History of Changes
Other Study ID Numbers: GraftJacket01
Study First Received: November 1, 2012
Last Updated: November 28, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014