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Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

NCT02029469 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-08-18

No results posted yet for this study

Summary

It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.

Conditions

  • Shoulder Arthritis Osteoarthritis
  • Rheumatoid Arthritis Shoulder
  • Acquired Deformity of Head
  • Post-traumatic Arthrosis of Other Joints, Shoulder Region

Interventions

DEVICE

Ascension HRA device

Patients who are treated with the Ascension® HRA for resurfacing of humeral head.

Sponsors & Collaborators

  • Ascension Orthopedics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sam Hakki, M.D. · Bay Pines VA Health Care System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02029469 on ClinicalTrials.gov