Arthroscopic Resection Arthroplasty of Carpometacarpal and/or Pantrapezial Osteoarthritis

Thumb Osteoarthritis Clinical Trial

— ARA:BJA-OA  

Official title:

Arthroscopic Resection Arthroplasty of Basal Joint Arthritis: Comparing Outcomes of Isolated Carpometacarpal to Pantrapezial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958137
• Other study ID #: Osquadcities
• Status: Completed
• Phase: N/A
• First received: October 27, 2016
• Last updated: November 4, 2016
• Start date: January 2004
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Orthopaedic Specialist, PC, Davenport, IA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Compare outcomes of ARA for isolated CMC OA versus to simultaneous ARA of CMC plus STT

Description:

The purposes of this study were to report 1) long-term outcomes on a large series of patients that underwent arthroscopic resection arthroplasty (ARA) for thumb basal joint arthritis (BJA) and 2) to compare outcomes of ARA for isolated carpometacarpal osteoarthritis versus those undergoing simultaneous ARA of CMC plus the scaphotrapeziotrapezoid joint for pantrapezial disease.

Please note, all patients treated by Dr. Cobb for CMC and/or STT OA received the same treatment regardless of whether or not they chose to participate in the study. Patients who chose to enroll in the study received the same treatment as those who did not only their data was analyzed. Data collection is the same for those who do not participate, only their data is not analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 83 Years

Eligibility

Inclusion Criteria:

• Primary cases of ARA for thumb BJA with isolated CMC ARA or simultaneous ARA of the CMC and STT joints.

Exclusion Criteria:

• Exclusions included 19 cases that received interposition materials that since have been shown to produce unfavorable postoperative inflammatory responses, (Orthadapt Bioimplant, Pegasus Biologics, Irvine, CA and Artimplant Artelon CMC-I Spacer, Small Bone Innovations, LLC, New York, NY), 6 cases that had prior CMC surgery, and 27 cases that underwent concomitant surgeries that would potentially effect outcome.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Procedure:
• Arthroscopic Resection Arthroplasty
Surgical removal of the arthritic joint(s) using a minimally invasive technique.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Specialist, PC, Davenport, IA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength (pinch and grip)		Change from baseline to 2 year follow-up.	No
Secondary	Satisfaction with Perceived Surgical Outcome	(0-5; 0 = not at all satisfied, 5 = completely satisfied)	Reported at 2 year postoperative follow-up	No
Secondary	Pain	numerical rating scale, (0-10; 0 = no pain, 10 = worst imaginable pain)	Change from baseline to 2 year follow-up	No