Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
LifeNet Health
Information provided by (Responsible Party):
Paul S. Shapiro, M.D., William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01542515
First received: February 24, 2012
Last updated: December 12, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.
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.

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
Study Population

Men and women of all ages having the diagnosis of osteoarthritis of the thumb.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01542515

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
LifeNet Health
  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: December 12, 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 July 22, 2014