Clinical trial NCT05049993: Pyrocarbon Clinical Follow-up Study
Official title: Pyrocarbon Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis of the Shoulder
Avascular Necrosis
Traumatic Arthritis
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 76
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long-term follow-up of Pyrocarbon IDE patients.

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).


Eligibility 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)

Primary outcomes:
measure: Change from Baseline to last follow-up visit in ASES scores
timeFrame: Follow-up visits through 10 years Post-Op
Secondary outcomes:
measure: Change from Baseline to last follow-up visit in Constant Murley scores
timeFrame: Follow-up visits through 10 years Post-Op
measure: Change from Baseline to last follow-up visit in SANE scores
timeFrame: Follow-up visits through 10 years Post-Op
measure: Change from Baseline to last follow-up visit in Subject Satisfaction scores
timeFrame: Follow-up visits through 10 years Post-Op
measure: Change from Baseline to last follow-up visit in EQ-5D scores
timeFrame: Follow-up visits through 10 years Post-Op
measure: Number of device associated and procedure associated adverse events.
timeFrame: Follow-up visits through 10 years Post-Op
measure: Evaluation of operated shoulder range of motion
timeFrame: Follow-up visits through 10 years Post-Op
measure: Rates of revision surgeries.
timeFrame: Follow-up visits through 10 years Post-Op
Other outcomes:
Locations:
city: Denver
country: United States
facility: Western Orthopaedics
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Waldorf
country: United States
facility: Southern Maryland Orthopedics
state: Maryland
city: Minneapolis
country: United States
facility: Allina Health Orthopedics
state: Minnesota
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Medford
country: United States
facility: Southern Oregon Orthopedics
state: Oregon
Study officials:
affiliation: Stryker Nordic
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: