Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study

Terminated

• Conditions: Arthritis
• Interventions: Device: HRA

• Registration Number: NCT02369497
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.

Detailed Description

This study protocol will provide guidance to investigators wanting to perform 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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-11-04
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-17
• Last Update Submitted: 2015-02-17
• Study First Posted: 2015-02-24
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Any patient who is to be treated with the Ascension HRA is eligible for inclusion in this study. Therefore, Principal Investigators should attempt to recruit all patients at the study site who are treated with the Ascension HRA

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

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary cohort	HRA	Primary cohort of subjects who receive the HRA device.

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Score	2 years	The American Shoulder and Elbow Score is a functional outcome tool that has been validated for various shoulder conditions

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale for pain	2 years	Patient assessed score of pain in the shoulder
X-rays	2 years	X-rays are conducted to assess the location and placement of the HRA device in the shoulder
Adverse events	Surgery; 3 month, 6 month, 1 year and 2 years post-op	assessment of any adverse events that occur during the trial
Range of Motion	2 years	Assessment of range of motion in the shoulder

Trial Locations

Locations (1)

Bay Pines VA Healthcare System; 🇺🇸 Bay Pines, Florida, United States