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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01542515
Enrollment
22
Registered
2012-03-02
Start date
2009-03-31
Completion date
2014-07-31
Last updated
2014-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Keywords

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

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.

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.

Interventions

PROCEDUREMeniscal 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.

Sponsors

LifeNet Health
CollaboratorINDUSTRY
Corewell Health East
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 95 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder and Hand (DASH) Score5 yearsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026