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

Stryker Trauma and Extremities157 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Osteoarthritis Avascular Necrosis Traumatic Arthritis

Interventions

Aequalis Pyrocarbon Humeral HeadDEVICE

Hemi Shoulder Arthroplasty

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Rate of Patient Success at 24 Months.

A subject is a success at 24 months if: * Their change in Constant score is greater than or equal to 17 and * They did not have revision surgery; and * There is no radiographic evidence of system disassembly or fracture, and * They did not have a system-related serious adverse event.

Time frame: 24 Months

Secondary Outcomes

Constant Score

Constant Score: In this score, 35 points are allocated for subjective assessments of pain and activities of daily living and 65 points are available for objective measures of range of movement and shoulder strength. A young healthy patient can therefore have a maximum score of 100 points. The minimum score is 0 points. The range of the score is 0-100 for both the Constant Score and the adjusted Constant score. A higher value represents a better outcome. Average of 2 pain scores (15 points max) Sum of 4 activities of daily living questions (20 points max) Sum of 4 ROM measure (40 points max) Power score (25 points max) Change in Constant Score and Adjusted Constant Score at 24 months compared to baseline is presented along with absolute values.

Time frame: 24 Months

American Shoulder and Elbow Surgeons (ASES) Score

American Shoulder and Elbow Surgeons Standardized Shoulder Assessment. The original ASES consists of 2 portions, a medical professional assessment section and a patient self-report section. The patient self-report section utilized in this study is a condition specific scale intended to measure functional limitations and pain of the shoulder. The assessment takes approximately 5 minutes to complete and consists of 2 dimensions: pain and activities of daily living. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points. The minimum score is 0 and the maximum score is 100. A higher value represents a better outcome. Change in American Shoulder and Elbow Surgeons (ASES) Score at 24 months compared to baseline are presented.

Data from ClinicalTrials.gov

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