NCT06320925

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 5, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2.6 years

First QC Date

March 13, 2024

Last Update Submit

May 22, 2025

Conditions

Shoulder InjuriesKnee InjuriesHip Injuries

Outcome Measures

Primary Outcomes (3)

  • ASES

    Change from baseline

    6 months

  • iHOT-12

    Change from baseline

    6 months

  • mHHS

    Change from baseline

    6 months

Study Arms (1)

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.

Device: Standard of Care Treatment

Interventions

Standard of Care TreatmentDEVICE

Subject has undergone joint space repair using one of the study devices and meets eligibility criteria

Study Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Subject was ≥ 18 years of age at the time of the surgery
  • Subject has undergone joint space repair using one of the study devices

You may not qualify if:

  • Subjects who are less than 6 months post-intervention
  • Concurrent participation in an investigational clinical study during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Musculoskeletal-Orthopedic Research and Education Foundation

Phoenix, Arizona, 85023, United States

RECRUITING

Steadman Hawkins Clinic Denver

Englewood, Colorado, 80112, United States

RECRUITING

TSAOG Orthopaedics & Spine

San Antonio, Texas, 78258, United States

RECRUITING

MeSH Terms

Conditions

Shoulder InjuriesKnee InjuriesHip Injuries

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Central Study Contacts

Hayley Taylor, MS

CONTACT

8057054206hayley.taylor@stryker.com

Colleen Roden, MS

CONTACT

9312672041colleen.roden@stryker.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 20, 2024

Study Start

December 5, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)