Osteoarthrosis of the Carpometacarpal Joint of the ThumbNCT01724840
GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis
A study testing GraftJacket and Tendon Interposition in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthrosis of the Carpometacarpal Joint of the Thumb
- What is being tested?
- GraftJacket and Tendon Interposition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients diagnosed for TMC OA
- willing to participate and provide informed consent
Who cannot join
- Patients with rheumatoid arthritis,
- pregnant women,
- legal incompetent patients,
- persons with insufficient knowledge of the German language to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
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.
Read the 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.
- Being tested
- GraftJacket, Tendon Interposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GraftJacketProcedure or surgery
Interposition with GraftJacket
Tendon InterpositionProcedure or surgery
Tendon Interposition with the FCR tendon
| Study group | Role | What they receive |
|---|---|---|
| GraftJacket | Experimental | GraftJAcket is used as interpositional material Receives: Procedure: GraftJacket |
| Tendon Interposition | Active comparator | Flexor carpi radialis tendon is used as interpositional material Receives: Procedure: Tendon Interposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery
Measured: preOP, 6 weeks, 3, 6, and 12months post OP
Secondary outcomes (1)
Secondary objectives are the comparison of the complications associated with the different surgical procedures as well as a cost-utility analysis.
Measured: preOP, 6 weeks, 3, 6, and 12months post OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthrosis of the Carpometacarpal Joint of the ThumbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Herren, Schulthess Klinik
- Investigators
- Daniel B Herren, MD, MHA, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724840
- Sponsor's protocol ID
- GraftJacket01
- Status last verified
- Aug 2016
- First submitted
- 1 Nov 2012
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection Suspension Arthroplasty With Interposition of GraftJacket Versus Tendon Interposition for Trapeziometacarpal Osteoarthritis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01724840
- Acronym / sponsor ID
- GraftJacket01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GraftJacket | Experimental | Procedure: GraftJacketGraftJAcket is used as interpositional material |
| Tendon Interposition | Active comparator | Procedure: Tendon InterpositionFlexor carpi radialis tendon is used as interpositional material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients diagnosed for TMC OA
- willing to participate and provide informed consent
Key exclusion criteria (4 listed)
- Patients with rheumatoid arthritis,
- pregnant women,
- legal incompetent patients,
- persons with insufficient knowledge of the German language to complete the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GraftJacketInterposition with GraftJacket | Procedure or surgery | GraftJacket |
| Tendon InterpositionTendon Interposition with the FCR tendon | Procedure or surgery | Tendon Interposition |
Primary outcome
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery
Time frame: preOP, 6 weeks, 3, 6, and 12months post OP
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Herren, MD, MHA principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GraftJacket and Tendon Interposition in people with Osteoarthrosis of the Carpometacarpal Joint of the Thumb, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain subscale of the Michigan Hand Questionnaire, 1 year following surgery (time frame: preOP, 6 weeks, 3, 6, and 12months post OP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.