Follow-up of Arthrosurface HemiCAP Implants

March 4, 2021 updated by: The Cleveland Clinic
Follow-up of Arthrosurface HemiCAP shoulder implants.

Study Overview

Status

Completed

Conditions

Detailed Description

In summary, the investigators would like to contact all patients who have had HemiCAP implants done at CCF with at least 2 years of follow-up after their procedure. The investigators will use electronic or written means to alert the patients that they will be contacted by our team to discuss their surgery and any related issues. Once the appropriate consent is obtained, the investigators will use a brief telephone interview to ask the patients several questions regarding any re-operations or complications the patients have had since the index procedure.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44125
        • Cleveland Clinic

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic

Description

Inclusion Criteria:

-Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic

Exclusion Criteria:

  • Anyone who has not had ARthrosurface (Franlin, MA) HeiCAP implants placed into their shoulders at the Cleveland Clinic

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arthrosurface
Time Frame: 2 year
survival curve for the implant
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of revision surgeries
Time Frame: 2 year
rate of revision surgeries
2 year

Collaborators and Investigators

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

Sponsor

The Cleveland Clinic

Collaborators

Arthrosurface, Inc.

Investigators

  • Principal Investigator: Kurt Spindler, MD, The Cleveland Clinic

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 (Actual)

January 31, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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