Trials Sponsors Conditions Drugs Pricing

Conditions

Arthroplasty Complications Osteo Arthritis Shoulders

Keywords

Medical DeviceSafetyPerformance

Outcome Measures

Primary Outcomes (2)

Kaplan Meier Implant Survivorship
This will be established by recording the incidence and frequency of device revisions. Kaplan-Meier survival analysis is a statistical method that estimates survival rates over time and accounts for factors that can affect implant survival.
Up to 10 Years
Safety Assessement
This will be established by recording the incidence and frequency of complications and adverse events. Relation of the events to the implant and/or procedure will be specified.
Up to 10 Years

Secondary Outcomes (1)

Assessment of performance and clinical benefits by recording patient reported QuickDASH
Up to 10 Years

Study Arms (1)

Comprehensive Regenerex Tissue Attachment Augments

Regenerex Tissue Attachment Augments were used in combination with the Comprehensive Segmental Revision system

Device: Regenerex Tissue Attachment Augments

Interventions

Regenerex Tissue Attachment AugmentsDevice

Patient will have been previously implanted with Regenerex Tissue Attachment Augments in combination with the Comprehensive Segmental Revision System

Comprehensive Regenerex Tissue Attachment Augments

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects must meet the inclusion criteria to be enrolled into the study. Subjects who meet any of the exclusion criteria should not be enrolled into the study. The study population will comprise a consecutive cohort of up to 103 subjects implanted using the Comprehensive SRS Regenerex Tissue Attachment Augments.

You may qualify if:

Patient must be 18 years of age or older.

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

Toman Orthopedics and Sports Med

Boca Raton, Florida, 33432, United States

Study Officials

Erin Osborn
Zimmer Biomet
STUDY DIRECTOR

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 27, 2024

Study Start

October 22, 2024

Actual (reported)

Comprehensive SRS Regenerex Tissue Attachment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Comprehensive Regenerex Tissue Attachment Augments

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Comprehensive Regenerex Tissue Attachment Augments

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations