Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

NCT ID: NCT02029469

Last Updated: 2014-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2014-07-31

Brief 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.

Detailed Description

At each assessment interval, information on complications and adverse events will be collected. In addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). Patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (VAS). Furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRA Device

Patients who will be treated with Ascension HRA device.

Group Type: EXPERIMENTAL

Ascension HRA device

Intervention Type: DEVICE

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

Interventions

Ascension HRA device

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

Intervention Type: DEVICE

Other Intervention Names

Ascension Metal HRA device

Eligibility Criteria

Inclusion Criteria

• The following patient will be included in the study - Patient who:

• Is treated with the Ascension HRA;
• Is disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis;
• Has mild or moderate humeral head deformity and /or limited motion;
• Has post-traumatic arthritis;
• Has an intact or reparable rotator cuff;
• Has the means and ability to return for all required study visits
• Is willing to participate in the study;
• Has signed an Informed Consent Form;
• Is at least 18 years of age and skeletally mature at the time of surgery;
• Is less than 75 years of age at the time of surgery

Exclusion Criteria

The following patients will be excluded from the study - Patients who:

• Infection, sepsis, and osteomyelitis;
• Osteoporosis;
• Metabolic disorders which may impair bone formation;
• Osteomalacia;
• Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray;
• Revision procedures where other devices or treatments have failed
• Refuses to be in the study; or does not have the means and ability to return for all required study visits;
• Currently participating in another clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascension Orthopedics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Hakki, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bay Pines VA Health Care System

Locations

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Countries

United States

Other Identifiers

CP- HRA-001

Identifier Type: -

Identifier Source: org_study_id