SportsPro: Post-Market Clinical Follow Up Study

Knee Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320925
• Other study ID #: SYK-SM-2022-02
• Status: Recruiting
• Start date: December 5, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Stryker Endoscopy
• Contact: Hayley Taylor, MS
• Phone: 8057054206
• Email: hayley.taylor[@]stryker.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 1, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Injuries
• Knee Injuries
• Shoulder Injuries
• Wounds and Injuries

Intervention

Device:
• Standard of Care Treatment
Subject has undergone joint space repair using one of the study devices and meets eligibility criteria

Locations

Country	Name	City	State
United States	Steadman Hawkins Clinic Denver	Englewood	Colorado
United States	Musculoskeletal-Orthopedic Research and Education Foundation	Phoenix	Arizona
United States	TSAOG Orthopaedics & Spine	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASES	Change from baseline	6 months
Primary	iHOT-12	Change from baseline	6 months
Primary	mHHS	Change from baseline	6 months