SportsPro: Post-Market Clinical Follow Up Study

March 20, 2024 updated by: Stryker Endoscopy

A Retrospective, Multi-Center, Post-Market Clinical Follow-Up Study of Stryker Class IIb Implants

Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to leverage standard of care data to provide further characterization of clinical outcomes following shoulder, hip and knee joint surgeries.

  • Primary Objective: To describe clinical outcomes of the Stryker Device in the shoulder, hip, and knee joints 6 months after surgical intervention.
  • Secondary Objective: To describe clinical outcomes of the Stryker Device in the shoulder, hip, and knee joints 3 months after surgical intervention.
  • Safety Objective: To describe safety of the Stryker implants in the shoulder, hip, and knee joints 6 months after intervention.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Recruiting
        • Musculoskeletal-Orthopedic Research and Education Foundation
        • Contact:
        • Principal Investigator:
          • Michael Amini, MD
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Recruiting
        • Steadman Hawkins Clinic Denver
        • Principal Investigator:
          • James Genuario, MD
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • TSAOG Orthopaedics & Spine
        • Principal Investigator:
          • Robert Hartzler, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone a surgical procedure (per indications for use) using the Stryker implants who meet all of the inclusion/exclusion criteria will be screened and enrolled by participating Investigators.

Description

Inclusion Criteria:

  1. Subject was ≥ 18 years of age at the time of the surgery
  2. Subject has undergone joint space repair using one of the study devices

Exclusion Criteria:

  1. Subjects who are less than 6 months post-intervention
  2. Concurrent participation in an investigational clinical study during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Subjects
Patients who have undergone a surgical procedure (per product indications for use) using the Stryker implants who meet all of the following criteria will be screened and enrolled by participating Investigators.
Device: Standard of Care Treatment
Subject has undergone joint space repair using one of the study devices and meets eligibility criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASES
Time Frame: 6 months
Change from baseline
6 months
iHOT-12
Time Frame: 6 months
Change from baseline
6 months
mHHS
Time Frame: 6 months
Change from baseline
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Endoscopy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYK-SM-2022-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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