Skip to content

GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis

Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01724840
Enrollment
60
Registered
2012-11-12
Start date
2012-09-30
Completion date
2015-04-30
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthrosis of the Carpometacarpal Joint of the Thumb

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.

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.

Interventions

PROCEDUREGraftJacket

Interposition with GraftJacket

PROCEDURETendon Interposition

Tendon Interposition with the FCR tendon

Sponsors

Schulthess Klinik
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgerypreOP, 6 weeks, 3, 6, and 12months post OP

Secondary

MeasureTime frame
Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis.preOP, 6 weeks, 3, 6, and 12months post OP

Other

MeasureTime frame
Costs, Treatment satisfaction, objective and subjective functionpreOP, 6 weeks, 3, 6, and 12months post OP

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026