Actively Recruiting
A Retrospective, Multi-Center, Post-Market Clinical Follow-Up Study of Stryker Class IIb Implants
Led by Stryker Endoscopy · Updated on 2025-05-29
1500
Participants Needed
3
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to use existing medical data to better understand the clinical outcomes following surgeries involving shoulder, hip, and knee joints. It focuses on patients who have received Stryker implants, evaluating their progress and safety after these surgical interventions. The study gathers information from multiple centers to provide a broad view of how these devices perform in everyday clinical practice. Participants in this study have already undergone joint space repair using Stryker Class IIb implants as part of their standard care. The study does not involve new treatments but reviews medical records and standard care data collected during routine follow-up visits. The primary goal is to describe patient outcomes six months after surgery, with additional focus on safety and results at three months. Participants' involvement includes allowing researchers to review their medical records from the surgery and follow-up period. Researchers will assess outcomes using measures like the American Shoulder and Elbow Surgeons (ASES) score, the International Hip Outcome Tool (iHOT-12), and the modified Harris Hip Score (mHHS) at six months post-surgery. Safety of the implants will also be monitored through this data review. The study collects information retrospectively, so there are no additional visits or treatments, and participation duration depends on available records covering at least six months post-intervention.
CONDITIONS
Brief Title
SportsPro: Post-Market Clinical Follow Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject was 18 years of age or older at the time of the surgery
- Subject has undergone joint space repair using one of the study devices
You will not qualify if you...
- Subjects who are less than 6 months post-intervention
- Concurrent participation in an investigational clinical study during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who have undergone joint space repair using Stryker implants are observed for clinical outcomes and safety following their surgical intervention.
Visits at 3 months and 6 months post-surgery
Trial Site Locations
Total: 3 locations
1
Musculoskeletal-Orthopedic Research and Education Foundation
Phoenix, Arizona, United States, 85023
Actively Recruiting
2
Steadman Hawkins Clinic Denver
Englewood, Colorado, United States, 80112
Actively Recruiting
3
TSAOG Orthopaedics & Spine
San Antonio, Texas, United States, 78258
Actively Recruiting
Research Team
H
Hayley Taylor, MS
C
Colleen Roden, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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