MedTrace Logo

Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

NCT02501733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-09-25

No results posted yet for this study

Summary

This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.

Conditions

Interventions

DEVICE

Medacta GMK Sphere® Medial Knee Prosthesis

There is no consensus within the Arthroplasty community as to whether a traditional post and cam-style Posterior Stabilized total knee device is superior to a medial-pivot, more congruent device. However, the majority of surgeons seem to prefer the former, though there is a minority that uses the latter device with great success. To date, there have been few prospective trials directly comparing these devices, and none with the latest generation of Total Knee Arthroplasty implants. Almost all such studies have been retrospective and/or utilizing older generation devices.

Sponsors & Collaborators

  • Medacta USA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2024-12-05
Completion
2024-12-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02501733 on ClinicalTrials.gov