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

NCT01542515 | Completed

• 1 other identifier: 2008-298
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Arthritis

Keywords

Allograft; Arthroplasty; Basal Joint; carpometacarpal joint; Thumb; meniscus; osteoarthritis; Patients with Stages I - III arthritis of the the thumb carpometacarpal joint

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (1)

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

Interventions

Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb PROCEDURE

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.

Osteoarthritis of the carpometacarpal joint of the thumb

Eligibility Criteria

• Age: 25 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Stage I - III osteoarthritis / traumatic arthritis of the thumb.

Sponsors & Collaborators

• Corewell Health East: lead
• LifeNet Health: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (2)

• 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.

  PMID: 15781363 BACKGROUND

• Hommen 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.

  PMID: 17418331 BACKGROUND

MeSH Terms

Conditions

Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paul S. Shapiro, M.D.

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 2, 2012
• Study Start: March 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

US (1)