SportsPro: Post-Market Clinical Follow Up Study

Recruiting

• Conditions: Shoulder Injuries; Hip Injuries; Knee Injuries
• Interventions: Device: Standard of Care Treatment

• Registration Number: NCT06320925
• Lead Sponsor: Stryker Endoscopy

Brief Summary

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

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 Timeline

• Study Start: 2023-12-05
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Subjects	Standard of Care Treatment	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.

Primary Outcome Measures

Name	Time	Method
ASES	6 months	Change from baseline
mHHS	6 months	Change from baseline
iHOT-12	6 months	Change from baseline

Trial Locations

Locations (3)

Musculoskeletal-Orthopedic Research and Education Foundation; 🇺🇸 Phoenix, Arizona, United States

Steadman Hawkins Clinic Denver; 🇺🇸 Englewood, Colorado, United States

TSAOG Orthopaedics & Spine; 🇺🇸 San Antonio, Texas, United States