Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

NCT02029469 | Terminated

• 1 other identifier: CP- HRA-001
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Humeral Resurfacing; Humeral Resurfacing Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Range of Motion

  2 years

• VAS scale for pain

  2 years

• AP and axillary radiographs

  2 years

• Adverse events

  2 years and during entire trial

Study Arms (1)

HRA Device

EXPERIMENTAL

Patients who will be treated with Ascension HRA device.

Device: Ascension HRA device

Interventions

Ascension HRA device DEVICE

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

Also known as: Ascension Metal HRA device

HRA Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascension Orthopedics, Inc.: lead

Study Sites (1)

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

Location

Study Officials

• Sam Hakki, M.D.

  Bay Pines VA Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: January 8, 2014
• Study Start: October 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (1)