Perform Humeral System Study

Avascular Necrosis Clinical Trial

— PHS  

Official title:

Perform Humeral System Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05067543
• Other study ID #: 20D-W-PHS-RM
• Status: Enrolling by invitation
• Start date: September 12, 2021
• Est. completion date: December 1, 2033

Study information

• Verified date: January 2023
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 1, 2033
• Est. primary completion date: June 30, 2033
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older at the time of the informed consent or non-opposition (when applicable).

• Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).

• Willing and able to comply with the requirements of the study protocol.

• Considered a candidate for shoulder arthroplasty using a study device.

• Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion Criteria:

• Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)

• Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).

• Active local or systemic infection, sepsis, or osteomyelitis

• Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid

• Significant injury to the brachial plexus

• Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components

• Neuromuscular disease (e.g., joint neuropathy)

• Patient with known allergy to one of the product materials

• Metabolic disorders which may impair bone formation

• Patient pregnancy

• Planned for two-stage surgery

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Osteoarthritis Shoulder
• Post-traumatic Arthrosis of Other Joints, Shoulder Region

Intervention

Device:
• Tornier Perform Humeral - Stem
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.

Locations

Country	Name	City	State
Canada	Roth McFarlane Hand and Upper Limb Centre	London	Ontario
France	Orthopedic Center Santy	Lyon
Switzerland	Schulthess Klinik	Zürich
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Orthopedic Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Countries where clinical trial is conducted

United States,  Canada,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through Follow-Up visits through 24 months Post-Op
Secondary	Change from Baseline to last follow-up visit in Constant Murley scores	Combination of physician-completed and patient-reported portions to assess functional state of shoulder including range of motion; total score reported out of 100 measuring where lower scores indicate less function of the evaluated shoulder	Baseline through Follow-Up visits through 10 years Post-Op
Secondary	Change from Baseline to last follow-up visit in SANE scores	SANE = Single Assessment Numeric Evaluation; 1 item assessment of shoulder rating 0% to 100%	Baseline through Follow-Up visits through 10 years Post-Op
Secondary	Change from Baseline to last follow-up visit in Subject Satisfaction scores	Single, subjective question measuring patient satisfaction; assessed by improved, worsened, or no change in satisfaction	Baseline through Follow-Up visits through 10 years Post-Op
Secondary	Change from Baseline to last follow-up visit in EQ-5D scores	The EuroQol Five Dimensions Questionnaire (EQ-5D) questionnaire is a standardized instrument for use as a measure of quality of life. It is cognitively simple, takes only a few minutes to complete, and provides a simple descriptive profile as well as a single index value for quality of life that can be used in the clinical and economic evaluation of health care. The EQ-5D consists of a descriptive system which comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and a visual analog scale which measures the respondent's self-rated health on a 0-100 scale.	Baseline through Follow-Up visits through 10 years Post-Op
Secondary	Number of device associated and procedure associated adverse events.		Baseline through Follow-Up visits through 10 years Post-Op
Secondary	Rates of revision surgeries.		Baseline through Follow-Up visits through 10 years Post-Op
Secondary	Evaluation of radiological imaging of the affected shoulder	Images will be analyzed for bone characteristics (baseline and post-op) and device migration, component breakage, and radiolucency (post-op visits only).	Baseline through Follow-Up visits through 10 years Post-Op