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

NCT02424760 | Unknown

• 1 other identifier: 0907-T-INSPYRE-RM
• Study Type: observational
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Implants survival rates

  Number of device or procedure related adverse events

  up to 10 years follow-up

Secondary Outcomes (3)

• 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

  at 3-6 months, 1, 2, 5 and 10 years follow-up

• Radiographic criteria timely evolution

  at 3-6 months, 1, 2, 5 and 10 years follow-up

Interventions

Shoulder hemi-arthroplasty DEVICE

Also known as: Inspyre

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

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

You may qualify if:

• 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.

You may not qualify if:

• Acute proximal humeral fracture,
• Systemic or local infection,
• Rotator cuff tear,
• Instability of the humeral head,
• Axillary nerve palsy,
• Revision arthroplasty.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Officials

• Gilles WALCH, 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: April 20, 2015
• First Posted: April 23, 2015
• Study Start: March 1, 2011
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 16, 2019

Record last verified: 2018-04