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

Stryker Trauma and Extremities

Status

Completed

Conditions

Traumatic Arthritis

Osteoarthritis

Avascular Necrosis

Treatments

Device: Aequalis Pyrocarbon Humeral Head

Study type

Interventional

Funder types

Industry

Identifiers

NCT02525783

15A-T-PYC-R

Details and patient eligibility

About

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

Enrollment

157 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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.