SportsPro: Post-Market Clinical Follow Up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care Treatment.
- Who it may be relevant to
- Registry conditions: Shoulder Injuries, Knee Injuries, Hip Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Retrospective, Multi-Center, Post-Market Clinical Follow-Up Study of Stryker Class IIb Implants
Overview
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.
Interventions
- Device Standard of Care Treatment
Subject has undergone joint space repair using one of the study devices and meets eligibility criteria
Primary outcome measures
- ASES [Time frame: 6 months]
- iHOT-12 [Time frame: 6 months]
- mHHS [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Subject was ≥ 18 years of age at the time of the surgery
- Subject has undergone joint space repair using one of the study devices
Exclusion criteria
- Subjects who are less than 6 months post-intervention
- Concurrent participation in an investigational clinical study during the study period
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- Musculoskeletal-Orthopedic Research and Education Foundation — Phoenix
- Steadman Hawkins Clinic Denver — Englewood
- TSAOG Orthopaedics & Spine — San Antonio
Identifiers
NCT: NCT06320925 · SYK-SM-2022-02