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

NCT02525783 | Completed Results

• 1 other identifier: 15A-T-PYC-R
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Months

Secondary Outcomes (11)

• Constant Score

  24 Months

• American Shoulder and Elbow Surgeons (ASES) Score

  24 Months

• Single Assessment Numeric Evaluation (SANE)

  24 Months

• EQ-5D Index

  24 Months

• Pain Measured by a VIsual Analog Scale (VAS)

  24 Months

Study Arms (1)

Hemi Shoulder Arthroplasty

EXPERIMENTAL

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Device: Aequalis Pyrocarbon Humeral Head

Interventions

Aequalis Pyrocarbon Humeral Head DEVICE

Hemi Shoulder Arthroplasty

Hemi Shoulder Arthroplasty

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Matt Venegoni
• Organization: Stryker

matthew.venegoni@stryker.com

612-297-0939

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 17, 2015
• Study Start: December 1, 2015
• Primary Completion: July 19, 2019
• Study Completion: October 7, 2022
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)