Aequalis Resurfacing Head Study

An Observational Cohort Study Evaluating the Safety and Performance of Aequalis Resurfacing Head Implant in a Consecutive Series of Patients With Shoulder Arthroplasty

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.

Study Overview

• Status: Unknown
• Conditions: Avascular Necrosis of the Head of Humerus; Post-traumatic Arthrosis of Other Joints, Shoulder Region; Localized, Primary Osteoarthritis
• Intervention / Treatment: Device: Shoulder hemi-arthroplasty

Detailed Description

Resurfacing head implants allow restoring of the normal joint mechanics and stability of the shoulder with minimal bone resection and low peripheral fracture risk, while preserving humeral bone stock. Non cemented head implants also allow for an easy re-intervention if needed. The success of resurfacing implants largely depends on the etiology, with the best results in primary shoulder arthrosis, and the worst in post-traumatic and cuff-tear arthropathy.

The Aequalis® Resurfacing Humeral Head is designed to restore the humeral head. It shares the same indications as shoulder arthroplasty in general, including the various types of arthritis and conditions resulting in loss of joint cartilage, joint incongruity, pain, and stiffness. Resurfacing humeral head implants allow minimal bone resection while preserving humeral bone stock as compared to standard anatomic humeral implants.

However, few data are available on mid-term effects of the resurfacing head implant developed by Tornier. This Post-Marketing study is implemented for the Aequalis® Resurfacing Head in shoulder arthroplasty to collect medium and long-term clinical data on performance and safety. It is designed to collect data from consecutive series in European patients for at least 12 months of follow-up and up to 10 years. If possible, the study duration and collection of information will be prolonged. Further follow-up can be implemented, by amendments.

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival rate	Number or device or procedure related adverse events	up to 10-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Passive and active Abduction, external rotation and internal rotation will be assessed.	at 3-month, 1, 2, 5, 10 years follow-up
Change from baseline and previous visit in SSV.	The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	at 3-month, 1, 2, 5, 10 years follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timely evaluation of fixation and migration of the implant.	Presence of radiolucent line(s) around the implant (Radiological imaging : X-Rays of MRI).	at 3-month, 1, 2, 5, 10 years follow-up
Timely evaluation of glenoid status.	Radiological imaging (X-Rays or MRI).	at 3-month, 1, 2, 5, 10 years follow-up

Collaborators and Investigators

• Sponsor: Stryker Trauma GmbH
• Investigators: Principal Investigator: Lionel NEYTON, MD, Centre Orthopédique Santy, Lyon, FR

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Necrosis
• Other Study ID Numbers: 0908-T-RESURF-RM