Arthroscopic Resection Arthroplasty of Carpometacarpal and/or Pantrapezial Osteoarthritis (ARA:BJA-OA)

November 4, 2016 updated by: Tyson Cobb, MD, Orthopaedic Specialist, PC, Davenport, IA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with basal joint arthritis who were scheduled to undergo arthroscopic resection arthroplasty of the CMC and/or STT joints.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Isolated CMC
Arthroscopic Resection Arthroplasty of isolated CMC joint OA. Please note, this is standard practice of Dr. Cobb's for treatment of CMC and/or STT arthritis.
Procedure: Arthroscopic Resection Arthroplasty
Surgical removal of the arthritic joint(s) using a minimally invasive technique.
Other Names:
  • Arthroscopy
Pantrapezial
Arthroscopic Resection Arthroplasty of simultaneous ARA of both the CMC and the STT joints. Please note, this is standard practice of Dr. Cobb's for treatment of CMC and/or STT arthritis.
Procedure: Arthroscopic Resection Arthroplasty
Surgical removal of the arthritic joint(s) using a minimally invasive technique.
Other Names:
  • Arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Strength (pinch and grip)
Time Frame: Change from baseline to 2 year follow-up.
Change from baseline to 2 year follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Perceived Surgical Outcome
Time Frame: Reported at 2 year postoperative follow-up
(0-5; 0 = not at all satisfied, 5 = completely satisfied)
Reported at 2 year postoperative follow-up
Pain
Time Frame: Change from baseline to 2 year follow-up
numerical rating scale, (0-10; 0 = no pain, 10 = worst imaginable pain)
Change from baseline to 2 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopaedic Specialist, PC, Davenport, IA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Osquadcities

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All patient health information was protected and complied with data privacy legal requirements. Personally identifiable patient information was removed from the data set prior to data analysis.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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