Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty

NCT ID: NCT02525783

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-10-07

Brief Summary

The purpose of this study is to demonstrate safety and effectiveness of the Aequalis Pyrocarbon Humeral Head in hemiarthroplasty at 24 months.

Conditions

Osteoarthritis; Avascular Necrosis; Traumatic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemi Shoulder Arthroplasty

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Group Type: EXPERIMENTAL

Aequalis Pyrocarbon Humeral Head

Intervention Type: DEVICE

Hemi Shoulder Arthroplasty

Interventions

Aequalis Pyrocarbon Humeral Head

Hemi Shoulder Arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult subject 22 years or older.
• Scapula and proximal humerus must have reached skeletal maturity.
• Clinical indication for hemiarthroplasty due to primary diagnosis of arthritis or avascular necrosis. Primary arthritis for this study includes osteoarthritis with pain and/or post-traumatic arthritis.
• Willing and able to comply with the protocol.
• Willing and able to sign the informed consent formed (or the Legally Authorized Representative will sign for the subject).

Exclusion Criteria

• Active local or systemic infection, sepsis, or osteomyelitis.
• In the opinion of the clinician, there is insufficient bone stock to support implants in the humeral metaphysis or poor bone quality.
• In the opinion of the clinician, there is insufficient bone stock or excessive deformation of the native glenoid to allow normal functioning of the glenohumeral joint.
• In the clinician's opinion, the subject is unwilling or unable to be compliant with the recommendations of the healthcare professional.
• Metabolism disorders that could compromise bone formation, or Osteomalacia.
• Infection at or near the implant site, distant foci of infections that could spread to the site of the implant, or systemic infection.
• Rapid destruction of the joint, marked bone loss, or bone resorption apparent on X-ray.
• Known allergy or suspected allergy to implant materials.
• Female subjects who are pregnant or planning to become pregnant within the study period.
• Medical conditions or balance impairments that could lead to falls. Prior arthroplasty or prior failed rotator cuff repair on the affected shoulder; (successful rotator cuff surgery may be included).
• A rotator cuff that is not intact and cannot be reconstructed. Subjects with a massive rotator cuff tear (>5cm) will be excluded.
• Nonfunctional deltoid muscle.
• Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint).
• Known active metastatic or neoplastic diseases, Paget's disease, or Charcot's disease.
• Currently, within the last 6 months, or planning to be on chemotherapy or radiation.
• Known alcohol or drug abuse as defined by DSM-5.
• Taking greater than 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
• Currently enrolled in any clinical research study that might interfere with the current study endpoints.
• Known history of renal or hepatic disease/insufficiency.
• Anatomy cannot be replicated using current available system sizes.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

15A-T-PYC-R

Identifier Type: -

Identifier Source: org_study_id