NCT01542515

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 25 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-03-02
• Last updated: 2014-07-25

Locations

1 site across 1 country: United States