Perform® Humeral System - Fracture Study (PFX)

Traumatic Arthritis Clinical Trial

— PFX  

Official title:

Tornier Perform® Humeral System - Fracture Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773352
• Other study ID #: UE-01-2022
• Status: Recruiting
• Start date: August 31, 2023
• Est. completion date: September 1, 2033

Study information

• Verified date: April 2024
• Source: Stryker Trauma GmbH
• Contact: Monica Fleeman
• Phone: 251-465-5969
• Email: monica.fleeman[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture.

Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.

Description:

This is an International, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Perform® Fracture shoulder system in both the anatomic and reversed configurations.

The primary endpoint of this study is to demonstrate decreased pain and improved subjects' shoulder functionality of daily living by achieving a mean of American Shoulder and Elbow Surgeons (ASES) shoulder score higher than 62 points, at 2-year follow-up post-operatively, regardless of configuration (anatomic or reverse).

Retrospective inclusions are allowed: preoperative and intra operative data can be collected retrospectively up to 2 months after the surgery date.

Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification.

Safety and performance data will be collected at surgery, immediate post-op, and up to 10 years post-operation. Patient Reported Outcome Measures (PROMs), device revision and Adverse Events (AEs) will be assessed annually throughout the study.

Range of Motion (ROM), strength and radiographic imaging assessments of the study shoulder will also be performed for in-person milestones visits at 6 months (radiographic imaging assessments), 1-, 2-, 5- and 10-year, post-operatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2033
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Informed and willing to sign an informed consent form (ICF) 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 with the device for shoulder joint disabled by:

• Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures

• Fracture sequelae

• Revisions where adequate fixation can be achieved, and adequate bone stock remains after final reconstruction

• Proximal humerus bone defect (reverse configuration)

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 subjects, including minor subjects, those unable to decide for themselves to participate or needing a LAR, or others who could be subject to coercion (subjects who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm)

• Any absolute contraindications as mentioned in the device Instruction For Use (available on ifu.stryker.com)

Related Conditions & MeSH terms

• Fracture Humerus
• Fractures, Bone
• Humeral Fractures
• Traumatic Arthritis

Intervention

Device:
• Tornier Perform® Humeral System - Fracture
A replacement of shoulder joints for anatomic and reverse shoulder arthroplasty. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

Locations

Country	Name	City	State
United States	Tennessee Orthopaedic Alliance	Columbia	Tennessee
United States	University of Texas/UT Health	Houston	Texas
United States	University of Arkansas Medical Sciences	Little Rock	Arkansas
United States	More Foundation	Phoenix	Arizona
United States	Eisenhower Health Desert Orthopedic Center	Rancho Mirage	California
United States	Washington University	Saint Louis	Missouri
United States	California Pacific Orthopaedics	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 Month
Secondary	Constant Score	A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient. Collected at: 1, 2, 5, and 10 years.	24 Month
Secondary	SANE	Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal. Collected annually through 10 year visit.	24 Month
Secondary	EQ-5D-5L	Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status. Collected annually through 10 year visit..	24 Month
Secondary	Patient Satisfaction	Single subjective question "How satisfied are you with your shoulder?" Collected annually through 10 year visit.	24 Month
Secondary	Radiographic Findings	X-rays will be analyzed, when sufficient information is available, for bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification. X-rays will be collected at Baseline, 6 months, 1 year, 2 year, 5 year and 10 year.	24 Month
Secondary	Tuberosity healing	Tuberosity healing (bone union) (Boileau et al., 2002, 2013, 2019) is expected to be completed post-operatively at 6 months and assessed at 6 months and up to 1 year if tuberosity healing is not achieved at 6 months.	12 Month