ArthritisNCT01542515
Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
An observational study of Arthritis, run by Corewell Health East at 1 site in United States.
Trial summary
Hypothesis: The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb. A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Read more about this study
- Who is it for?
- Ages 25 to 95 years
- Conditions the study is for
- Arthritis
- What is being tested?
- Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2014
- Phase
- Observational
- 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 25 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women of all ages having the diagnosis of osteoarthritis of the thumb.
Who may be able to join
- Stage I - III osteoarthritis / traumatic arthritis of the thumb.
Who cannot join
- Exclusion criteria were diabetes mellitus, kidney insufficiency, OA in the STT joint, or malignancy within the past 10 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Hypothesis:
The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb.
A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Using the concept of an implant acting as a spacer and stabilizer the investigators proposed and implemented a novel surgical technique using allograft knee meniscus as a biologic implant for the treatment of basal joint arthritis of the thumb.
Read the detailed description
Hypothesis:
The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb.
Introduction:
A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Promising results were originally reported (2004) for the Artelon carpometacarpal (CMC) implant (Small Bone Innovations, Morrisville, PA) procedure which utilized the concept of a spacer and stabilizer of the CMC joint . Recent studies however, have demonstrated problems due to a foreign body reaction with the Artelon implant requiring revision surgery. Using the concept of an implant acting as a spacer and stabilizer we proposed and implemented the use of allograft knee meniscus as a biologic implant in the treatment of basal joint arthritis of the thumb
Methods:
A prospective study was performed on four thumbs using an allograft knee meniscus transplanted into the thumb CMC joint using the surgical technique described for that of the Artelon implant (Small Bone Innovations, Morrisville, PA). Data collected included: pain level, grip strength, tip, key and pinch strength, carpometacarpal, metacarpophalangeal, interphalangeal, and oppositional range of motion, as well as Disabilities of the Arm, Shoulder, and Hand (DASH) scores. Interval radiographic analysis is to be performed. Endpoints for data collection will be at three months, six months, one, two, three, four, and five years follow up.
- Conditions
- Arthritis
- Being tested
- Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb
- Keywords
- Allograft, Arthroplasty, Basal Joint, carpometacarpal joint, Thumb, meniscus, osteoarthritis, Patients with Stages I - III arthritis of the the thumb carpometacarpal joint
- Medical subject headings
- Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscal allograft arthroplasty of the carpometacarpal joint of the thumbProcedure or surgery
The surgical procedure will involve the use of human meniscal allograft tissue that will be provided by industry. The meniscus will be contoured into a "T" shape. The T-shaped meniscus allograft is then inserted into the arthritic thumb CMC joint and secured with two suture anchors.
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis of the carpometacarpal joint of the thumb | The group of patients enrolled in this study all have the diagnosis of carpometacarpal arthritis of the thumb. The patients did not respond favorably to non-operative management including oral anti-inflammatory medications, corticosteroid injections, and thumb splinting. Operative management was therefore recommended using the technique of meniscal allograft arthroplasty. Receives: Procedure: Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH) Score
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health
- Responsible party
- Principal investigator, Paul S. Shapiro, M.D., Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542515
- Sponsor's protocol ID
- 2008-298
- Status last verified
- Jul 2014
- First submitted
- 24 Feb 2012
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsson A, Liljensten E, Bergstrom C, Sollerman C. Results from a degradable TMC joint Spacer (Artelon) compared with tendon arthroplasty. J Hand Surg Am. 2005 Mar;30(2):380-9. doi: 10.1016/j.jhsa.2004.12.001.
PubMed 15781363Hommen JP, Applegate GR, Del Pizzo W. Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy. 2007 Apr;23(4):388-93. doi: 10.1016/j.arthro.2006.11.032.
PubMed 17418331
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
- ClinicalTrials.gov ID
- NCT01542515
- Acronym / sponsor ID
- 2008-298
- Conditions
- Arthritis
- Keywords
- Allograft, Arthroplasty, Basal Joint, carpometacarpal joint, Thumb, meniscus, osteoarthritis, Patients with Stages I - III arthritis of the the thumb carpometacarpal joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- LifeNet Health
- Study start
- Mar 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Mar 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.
Hypothesis:
The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb.
A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Using the concept of an implant acting as a spacer and stabilizer the investigators proposed and implemented a novel surgical technique using allograft knee meniscus as a biologic implant for the treatment of basal joint arthritis of the thumb.
Detailed description
Hypothesis:
The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb.
Introduction:
A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Promising results were originally reported (2004) for the Artelon carpometacarpal (CMC) implant (Small Bone Innovations, Morrisville, PA) procedure which utilized the concept of a spacer and stabilizer of the CMC joint . Recent studies however, have demonstrated problems due to a foreign body reaction with the Artelon implant requiring revision surgery. Using the concept of an implant acting as a spacer and stabilizer we proposed and implemented the use of allograft knee meniscus as a biologic implant in the treatment of basal joint arthritis of the thumb
Methods:
A prospective study was performed on four thumbs using an allograft knee meniscus transplanted into the thumb CMC joint using the surgical technique described for that of the Artelon implant (Small Bone Innovations, Morrisville, PA). Data collected included: pain level, grip strength, tip, key and pinch strength, carpometacarpal, metacarpophalangeal, interphalangeal, and oppositional range of motion, as well as Disabilities of the Arm, Shoulder, and Hand (DASH) scores. Interval radiographic analysis is to be performed. Endpoints for data collection will be at three months, six months, one, two, three, four, and five years follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis of the carpometacarpal joint of the thumb | – | Procedure: Meniscal allograft arthroplasty of the carpometacarpal joint of the thumbThe group of patients enrolled in this study all have the diagnosis of carpometacarpal arthritis of the thumb. The patients did not respond favorably to non-operative management including oral anti-inflammatory medications, corticosteroid injections, and thumb splinting. Operative management was therefore recommended using the technique of meniscal allograft arthroplasty. |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women of all ages having the diagnosis of osteoarthritis of the thumb.
Key inclusion criteria (1 listed)
- Stage I - III osteoarthritis / traumatic arthritis of the thumb.
Key exclusion criteria (1 listed)
- Exclusion criteria were diabetes mellitus, kidney insufficiency, OA in the STT joint, or malignancy within the past 10 years.
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 |
|---|---|---|
| Meniscal allograft arthroplasty of the carpometacarpal joint of the thumbThe surgical procedure will involve the use of human meniscal allograft tissue that will be provided by industry. The meniscus will be contoured into a "T" shape. The T-shaped meniscus allograft is then inserted into the arthritic thumb CMC joint and secured with two suture anchors. | Procedure or surgery | Osteoarthritis of the carpometacarpal joint of the thumb |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: 5 years
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
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 25 Jul 2014.
- Background: PubMed 15781363Nilsson A, Liljensten E, Bergstrom C, Sollerman C. Results from a degradable TMC joint Spacer (Artelon) compared with tendon arthroplasty. J Hand Surg Am. 2005 Mar;30(2):380-9. doi: 10.1016/j.jhsa.2004.12.001.
- Background: PubMed 17418331Hommen JP, Applegate GR, Del Pizzo W. Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy. 2007 Apr;23(4):388-93. doi: 10.1016/j.arthro.2006.11.032.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Corewell Health East at 1 site in United States.
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 1 inclusion and 1 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 25 Jul 2014. 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 United States. 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?
Disabilities of the Arm, Shoulder and Hand (DASH) Score (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01542515, which also lists 2 linked publications.
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 25 Jul 2014.