Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis Shoulder; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Shoulder Arthritis Osteoarthritis; Acquired Deformity of Head
• Intervention / Treatment: Device: Ascension HRA device

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRA Device; Patients who will be treated with Ascension HRA device.	Device: Ascension HRA device; Patients who are treated with the Ascension® HRA for resurfacing of humeral head.; Other Names: Ascension Metal HRA device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeon Score	The ASES score will be evaluated at 2 years and compared to baseline.	Outcome data will be evaluated at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Shoulder range of motion will be measured compared to baseline.	2 years
VAS scale for pain	VAS score for pain will be evaluated at 2 years and compared to baseline.	2 years
AP and axillary radiographs	Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.	2 years
Adverse events	AEs will be assessed at each study timepoint	2 years and during entire trial

Collaborators and Investigators

• Sponsor: Ascension Orthopedics, Inc.
• Investigators: Principal Investigator: Sam Hakki, M.D., Bay Pines VA Health care System

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Estimate): August 18, 2014
• Last Update Submitted That Met QC Criteria: August 15, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Humeral Resurfacing; Humeral Resurfacing Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CP- HRA-001