Shoulder InjuriesNCT06320925
SportsPro: Post-Market Clinical Follow Up Study
An observational study of Shoulder Injuries and Knee Injuries, run by Stryker Endoscopy at 3 sites in United States.
Trial summary
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries, Knee Injuries, Hip Injuries
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Dec 2023to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject was ≥ 18 years of age at the time of the surgery
- Subject has undergone joint space repair using one of the study devices
Who cannot join
- Subjects who are less than 6 months post-intervention
- Concurrent participation in an investigational clinical study during the study period
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Steadman Hawkins Clinic Denver
Englewood, Colorado, 80112
Lauren Heylmun, LAUREN.HEYLMUN@CUANSCHUTZ.EDU
James Genuario, MD
- Recruiting
Musculoskeletal-Orthopedic Research and Education Foundation
Phoenix, Arizona, 85023
Wafa Mohsin, wafa.mohsin@more-foundation.org
Michael Amini, MD
- Recruiting
TSAOG Orthopaedics & Spine
San Antonio, Texas, 78258
Amanda Strickland, astrickland@brioresearch.org
Robert Hartzler, MD
About this study
Official title: 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)
Read the 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.
- Conditions
- Shoulder Injuries, Knee Injuries, Hip Injuries
- Being tested
- Standard of Care Treatment
- Medical subject headings
- Shoulder Injuries, Knee Injuries, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care TreatmentDevice
Subject has undergone joint space repair using one of the study devices and meets eligibility criteria
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Standard of Care Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASES
Change from baseline
Measured: 6 months
iHOT-12
Change from baseline
Measured: 6 months
mHHS
Change from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start5 Dec 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stryker Endoscopy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320925
- Sponsor's protocol ID
- SYK-SM-2022-02
- Status last verified
- May 2025
- First submitted
- 13 Mar 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-Center, Post-Market Clinical Follow-Up Study of Stryker Class IIb Implants
- ClinicalTrials.gov ID
- NCT06320925
- Acronym / sponsor ID
- SYK-SM-2022-02
- Conditions
- Shoulder Injuries, Knee Injuries, Hip Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Stryker EndoscopyIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subjects | – | Device: Standard of Care TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Subject was ≥ 18 years of age at the time of the surgery
- Subject has undergone joint space repair using one of the study devices
Key exclusion criteria (2 listed)
- Subjects who are less than 6 months post-intervention
- Concurrent participation in an investigational clinical study during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care TreatmentSubject has undergone joint space repair using one of the study devices and meets eligibility criteria | Device | Study Subjects |
Primary outcome
ASES
Time frame: 6 months
Change from baseline
iHOT-12
Time frame: 6 months
Change from baseline
mHHS
Time frame: 6 months
Change from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Injuries and Knee Injuries, run by Stryker Endoscopy at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayley Taylor, MS (8057054206, hayley.taylor@stryker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASES (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.