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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542515
• Other study ID #: 2008-298
• Status: Completed
• Phase: N/A
• First received: February 24, 2012
• Last updated: July 24, 2014
• Start date: March 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 95 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	LifeNet Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hommen JP, Applegate GR, Del Pizzo W. Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy. 2007 Apr;23(4):388-93. — View Citation

Nilsson A, Liljensten E, Bergström 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No