Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Arthritis |
Procedure: Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb |
- Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
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Procedure: Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb
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.
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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.
Eligibility| Ages Eligible for Study: | 25 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Men and women of all ages having the diagnosis of osteoarthritis of the thumb.
Inclusion Criteria:
- Stage I - III osteoarthritis / traumatic arthritis of the thumb.
Exclusion Criteria:
- Exclusion criteria were diabetes mellitus, kidney insufficiency, OA in the STT joint, or malignancy within the past 10 years.
Contacts and Locations More Information
Publications:
| Responsible Party: | Paul S. Shapiro, M.D., William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT01542515 History of Changes |
| Other Study ID Numbers: | 2008-298 |
| Study First Received: | February 24, 2012 |
| Last Updated: | January 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by William Beaumont Hospitals:
|
Allograft Arthroplasty Basal Joint carpometacarpal joint |
Thumb meniscus osteoarthritis Patients with Stages I - III arthritis of the the thumb carpometacarpal joint |
Additional relevant MeSH terms:
|
Arthritis Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013