N/A
N=157
Aequalis Pyrocarbon IDE; Replacing the Humeral Head in Hemi-Arthroplasty
Osteoarthritis · Avascular Necrosis · Traumatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02525783 ↗Enrolled (actual)
157
Serious AEs
3.2%
Results posted
Jan 2023
Primary outcome: Primary: Rate of Patient Success at 24 Months. — 120 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aequalis Pyrocarbon Humeral Head (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Stryker Trauma and Extremities
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Patient Success at 24 Months. |
120 | — |
| SECONDARY Constant Score |
34.3; 39.5; 78.1 | — |
| SECONDARY American Shoulder and Elbow Surgeons (ASES) Score |
43.4; 87.5 | — |
| SECONDARY Single Assessment Numeric Evaluation (SANE) |
49.5; 85.4 | — |
| SECONDARY EQ-5D Index |
.21; .87 | — |
| SECONDARY Pain Measured by a VIsual Analog Scale (VAS) |
4.23; 1.14 | — |
| SECONDARY Range of Motion (ROM) |
33.5; 43.5; 37.5 | — |
| SECONDARY Strength |
5; 14.8 | — |
| SECONDARY Number of Participants With Device-related Serious Adverse Events |
5 | — |
| SECONDARY Revision Rate |
3 | — |
| SECONDARY Level of Satisfaction With the Shoulder |
111; 20; 8; 5 | — |
| SECONDARY X-Ray Data |
0; 0; 0; 78; 5; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02525783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.