Clinical trial NCT02525783: Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
Official title: Aequalis Pyrocarbon Humeral Head IDE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Avascular Necrosis
Traumatic Arthritis
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2015-08-17
Enrollment: 157
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Rate of Patient Success at 24 Months.
timeFrame: 24 Months
Secondary outcomes:
measure: Constant Score
timeFrame: 24 Months
measure: American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: 24 Months
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: 24 Months
measure: EQ-5D Index
timeFrame: 24 Months
measure: Pain Measured by a VIsual Analog Scale (VAS)
timeFrame: 24 Months
measure: Range of Motion (ROM)
timeFrame: 24 Months
measure: Strength
timeFrame: 24 Months
measure: Number of Participants With Device-related Serious Adverse Events
timeFrame: 24 Months
measure: Revision Rate
timeFrame: 24 Months
measure: Level of Satisfaction With the Shoulder
timeFrame: 24 Months
measure: X-Ray Data
timeFrame: 24 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References: