NCT02958137

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

7.9 years

First QC Date

October 27, 2016

Last Update Submit

November 4, 2016

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Strength (pinch and grip)

    Change from baseline to 2 year follow-up.

Secondary Outcomes (2)

  • Satisfaction with Perceived Surgical Outcome

    Reported at 2 year postoperative follow-up

  • Pain

    Change from baseline to 2 year follow-up

Study Arms (2)

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

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

Interventions

Arthroscopic Resection ArthroplastyPROCEDURE

Surgical removal of the arthritic joint(s) using a minimally invasive technique.

Also known as: Arthroscopy
Isolated CMCPantrapezial

Eligibility Criteria

Age35 Years - 83 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Arthroscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Hand and Upper Extremity Surgery

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 8, 2016

Study Start

January 1, 2004

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 8, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

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.