Treatment for Knee Replacement Surgery

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Knee Replacement Surgery
Eligibility
21 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing the long-term effects of two different types of knee replacements.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 10 years

10 years
A 10-year Kaplan Meier survival analysis will be presented including only prospective cases.
To compare the mean KSS Function Score at 10-years to the Triathlon Cruciate Retaining (CR) KSS Function Score at 10-years calculated combining prospective and retrospective cases.

Trial Safety

Safety Progress

1 of 3

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1
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Trial Design

0 Treatment Group

175 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor
60 Previous Clinical Trials
18,643 Total Patients Enrolled
Brett Greenky, MDPrincipal InvestigatorSyracuse Orthopedic Specialists
1 Previous Clinical Trials
352 Total Patients Enrolled
Paul Jacob, MDPrincipal InvestigatorOklahoma Sports Science and Orthopaedics
Matthew Phillips, MDPrincipal InvestigatorDepartment of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
Peter Bonutti, MDPrincipal InvestigatorBonutti Clinic
1 Previous Clinical Trials
250 Total Patients Enrolled
Soren Toksvig-Larsen, MDPrincipal InvestigatorHassleholm Sygehus Ortopaedkirurgisk afd.
Marco Tinius, MDPrincipal InvestigatorPraxisklinik Stollberg
Brian Aros, MDPrincipal InvestigatorMansfield Orthopaedics
R. David Heekin, M.D.Principal InvestigatorSt. Vincent's Medical Center
3 Previous Clinical Trials
144 Total Patients Enrolled
Fabio Orozco, MDPrincipal InvestigatorRothman Institute
Marco Schiraldi, MDPrincipal InvestigatorPresidlo Ospedaliero Civile Santi Antonio e Biagio

Eligibility Criteria

Age 21 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
The subject requires a primary cemented unicompartmental knee replacement.
The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
You have signed the IRB approved informed consent form.
References

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