NCT03247335

Brief Summary

Follow-up of Arthrosurface HemiCAP shoulder implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

August 9, 2017

Last Update Submit

March 4, 2021

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

  • Arthrosurface

    survival curve for the implant

    2 year

Secondary Outcomes (1)

  • Rate of revision surgeries

    2 year

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44125, United States

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Kurt Spindler, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 11, 2017

Study Start

January 31, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)