Clinical trial NCT01542515: Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
Official title: Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Keywords: Allograft
Arthroplasty
Basal Joint
carpometacarpal joint
Thumb
meniscus
osteoarthritis
Patients with Stages I - III arthritis of the the thumb carpometacarpal joint
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: LifeNet Health
First posted: 2012-03-02
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women of all ages having the diagnosis of osteoarthritis of the thumb.

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.

Eligibility 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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
References:
citation: 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.
citation: 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.