Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant

A Prospective Cohort Study to Document the Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant

The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies. The rotator cuff must be functional.

The aim of this study is to prospectively collect data from consecutive series to implement a Post Marketing Surveillance plan.

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

Degenerative shoulder pathologies associated with a functional rotator cuff are currently treated by hemi-arthroplasty or total prosthesis replacement. The choice of surgery process is mainly made according to the status of the glenoid.

Concerning hemi-arthroplasty, two types of humeral prosthesis are usually used: anatomical stems or resurfacing head implants. Both provide good results. Nevertheless with these prostheses, patient can present with post-operative pains due to glenoid erosion, linked to the metallic compounds used in such a prostheses. To face this issue, it was decided to modify the metallic compounds, and in order to mimic the tribological properties of the cartilage, Pyrocarbon (PyC) was found to be the best material.

First application of PyC in a medical device was for cardiac valves in 1969. Currently more than 2 million people live with PyC cardiac valves. Mechanical and physical properties of PyC are in favor of its use in orthopedic surgery; furthermore, its biocompatibility plays an important role in its good acceptability.

As very good results were observed when used in hand and wrist, interposition PyC implant was suggested for shoulder. Another advantage was that such interposition device allowed performing less invasive surgery, a particularly important criteria for young patients.

INSPYRE shoulder prosthesis was then designed as a shoulder interposition implant intended for partial replacement of the gleno-humeral joint. This implant is inserted between the glenoid cartilage and the humeral metaphyseal cavity. It is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies, e.g., osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head. The rotator cuff must be functional.

• Study Type: Observational
• Enrollment (Actual): 67

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

Study population is a continuous series of the first 67 patients having received an Inspyre implant in the 8 participating sites.

Description

Inclusion Criteria:

• patients requiring a Humeral Head Replacement (HHR) with INSPYRE as per indication of the Instruction For Use:
• with degenerative indication such as primary Gleno Humeral (GH) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
• presenting a functional rotator cuff,
• able to return for all scheduled and required study visit;
• having provided informed Consent about scientific study participation if applicable.

Exclusion Criteria:

• Acute proximal humeral fracture,
• Systemic or local infection,
• Rotator cuff tear,
• Instability of the humeral head,
• Axillary 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
Implants survival rates	Number of device or procedure related adverse events	up to 10 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline and previous visit in Constant Murley score		at 1, 2, 5 and 10 years follow-up
Change from baseline and previous visit in Range of Motion	Forward flexion, Internal rotation and external rotation will be assessed	at 3-6 months, 1, 2, 5 and 10 years follow-up
Radiographic criteria timely evolution	Glenoid erosion, tuberosities thinning, lateralization index, subacromial space and implant subsidence will be assessed according to available R-ray, CT or MRI	at 3-6 months, 1, 2, 5 and 10 years follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 23, 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: 0907-T-INSPYRE-RM