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

Ascension® Humeral Resurfacing Arthroplasty HRA Follow-Up Study

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

Study Overview

• Status: Terminated
• Conditions: Arthritis
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with arthritis requiring humeral resurfacing arthroplasty

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary cohort; Primary cohort of subjects who receive the HRA device.	Device: HRA; Humeral head resurfacing with the HRA device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Candi Langmaid, MPH, CCRP, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CP-HRA-001