Aequalis Resurfacing Head Study

NCT02444299 | Unknown

• 1 other identifier: 0908-T-RESURF-RM
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007. The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.

Conditions

Localized, Primary Osteoarthritis; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Avascular Necrosis of the Head of Humerus

Outcome Measures

Primary Outcomes (1)

• Implant survival rate

  Number or device or procedure related adverse events

  up to 10-year follow-up

Secondary Outcomes (3)

• Change from baseline and previous visit in Constant Murley score

  at 3-month, 1, 2, 5, 10 years follow-up

• Change from baseline and previous visit in Range Of Motion

  at 3-month, 1, 2, 5, 10 years follow-up

• Change from baseline and previous visit in SSV.

  at 3-month, 1, 2, 5, 10 years follow-up

Other Outcomes (2)

• Timely evaluation of fixation and migration of the implant.

  at 3-month, 1, 2, 5, 10 years follow-up

• Timely evaluation of glenoid status.

  at 3-month, 1, 2, 5, 10 years follow-up

Interventions

Shoulder hemi-arthroplasty DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from 6 centers in Europe where shoulder arthroplasty with Aequalis® Resurfacing Head is performed. The first 100 patients treated in the centers will be included then followed-up, until the 10 years follow-up visit.

You may qualify if:

• Patient has received an Aequalis® Resurfacing Head implant as per the manufacturer's instructions (including the recommended indication): degenerative indication such as primary osteoarthritis, secondary osteoarthritis (post-traumatic post instability), avascular osteonecrosis of the humeral head ;
• with a functional rotator cuff ;
• has clinical and radiographic follow-up data available ;
• is informed about the study and has provided Informed Consent as applicable.

You may not qualify if:

• Patient with proximal humeral fracture,
• previous history of infection,
• rotator cuff tear, cuff tear arthropathy,
• significant bone loss of the glenoid (more than 25% of the articular surface),
• nerve palsy,
• revision arthroplasty.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Officials

• Lionel NEYTON, MD

  Centre Orthopédique Santy, Lyon, FR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2011
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 16, 2019

Record last verified: 2018-04