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CompletedNCT03247335Updated Mar 8, 2021

Follow-up of Arthrosurface HemiCAP Implants

An observational study in Orthopedic Disorder, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
75
Sex
All
01

Study summary

Follow-up of Arthrosurface HemiCAP shoulder implants.

Read the 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.

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Conditions studied

  • Orthopedic Disorder
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In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 75 is below the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Anyone who has not had ARthrosurface (Franlin, MA) HeiCAP implants placed into their shoulders at the Cleveland Clinic
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
75 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Arthrosurface

    survival curve for the implant

    Time frame: 2 year

Secondary outcomes

  1. Rate of revision surgeries

    rate of revision surgeries

    Time frame: 2 year

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Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44125, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03247335
Lead sponsor
The Cleveland Clinic
Collaborators
Arthrosurface, Inc.
Responsible party
Sponsor
First posted
Aug 11, 2017
Start date
Jan 31, 2018
Primary completion
Aug 1, 2019
Completion
Aug 1, 2019
Last update
Mar 8, 2021

Study contacts

Kurt Spindler, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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