NCT05049993

Brief Summary

The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Oct 2021Dec 2027

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5.6 years

First QC Date

September 9, 2021

Last Update Submit

February 9, 2026

Conditions

Osteoarthritis of the ShoulderAvascular NecrosisTraumatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to last follow-up visit in ASES scores

    ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function

    Follow-up visits through 10 years Post-Op

Secondary Outcomes (7)

  • Change from Baseline to last follow-up visit in Constant Murley scores

    Follow-up visits through 10 years Post-Op

  • Change from Baseline to last follow-up visit in SANE scores

    Follow-up visits through 10 years Post-Op

  • Change from Baseline to last follow-up visit in Subject Satisfaction scores

    Follow-up visits through 10 years Post-Op

  • Change from Baseline to last follow-up visit in EQ-5D scores

    Follow-up visits through 10 years Post-Op

  • Number of device associated and procedure associated adverse events.

    Follow-up visits through 10 years Post-Op

  • +2 more secondary outcomes

Interventions

Aequalis Pyrocarbon Humeral HeadDEVICE

Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Long-term follow-up of Pyrocarbon IDE patients.

You may qualify if:

  • Subject in the Pyrocarbon IDE Study and has not had the device explanted.
  • Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
  • Willing and able to comply with the requirements of the study protocol

You may not qualify if:

  • Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

HCA HealthONE, LLC

Denver, Colorado, 80218, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Southern Maryland Orthopedics

Waldorf, Maryland, 20602, United States

Location

Allina Health Orthopedics

Minneapolis, Minnesota, 55407, United States

Location

Missouri Orthopaedic Institute

Columbia, Missouri, 65211, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

Location

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rebecca Gibson

    Stryker Trauma & Extremities

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

October 27, 2021

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)