Pyrocarbon Clinical Follow-up Study

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

• 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05049993
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stryker Trauma GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rebecca Gibson
Principal Investigator Affiliation Stryker Nordic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis of the Shoulder, Avascular Necrosis, Traumatic Arthritis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Western Orthopaedics, Denver, Colorado

Status

Address

Western Orthopaedics

Denver, Colorado, 80218

Holy Cross Hospital, Fort Lauderdale, Florida

Status

Address

Holy Cross Hospital

Fort Lauderdale, Florida, 33308

Tulane University, New Orleans, Louisiana

Status

Address

Tulane University

New Orleans, Louisiana, 70112

Southern Maryland Orthopedics, Waldorf, Maryland

Status

Address

Southern Maryland Orthopedics

Waldorf, Maryland, 20602

Allina Health Orthopedics, Minneapolis, Minnesota

Status

Address

Allina Health Orthopedics

Minneapolis, Minnesota, 55407

Missouri Orthopaedic Institute, Columbia, Missouri

Status

Address

Missouri Orthopaedic Institute

Columbia, Missouri, 65211

Duke University, Durham, North Carolina

Status

Address

Duke University

Durham, North Carolina, 27705

Southern Oregon Orthopedics, Medford, Oregon

Status

Address

Southern Oregon Orthopedics

Medford, Oregon, 97504