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Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Primary Purpose

Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medacta GMK Sphere® Medial Knee Prosthesis
Sponsored by
Medacta USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total Knee Replacement, Total Knee Arthroplasty

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients willing to sign the informed consent
  • Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self evaluations.
  • Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery.
  • Patients requiring a primary total knee replacement.
  • Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  • Patients with intact collateral ligaments.

Exclusion Criteria:

  • Patients with inflammatory arthritis.
  • Patients that are morbidly obese, body mass index (BMI) > 40.
  • Patients with a history of total or unicompartmental reconstruction of the affected joint.
  • Patients that have had a high tibial osteotomy or femoral osteotomy.
  • Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
  • Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
  • Patients that are immunologically compromised, or receiving chronic steroids (> 30 days).
  • Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
  • Patients with knee fusion to the affected joint.
  • Patients with an active or suspected latent infection in or about the knee joint.
  • Patients that are prisoners.

Sites / Locations

  • Norhtwestern University
  • Tulane University
  • McBride Orthopedic Hospital
  • Texas Orthopedics
  • Spokane Joint Replacement Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Medacta GMK Sphere® Knee Prosthesis

Arm Description

All subjects enrolled will receive the Medacta GMK Sphere® Medial Knee Prosthesis

Outcomes

Primary Outcome Measures

Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively.
Knee function-patients ability to forget the artificial joint in everyday life.

Secondary Outcome Measures

Total Knee Society Score (KSS)
Total Knee Society score questionnaire to assess pain and function
Krackow Activity Scale (KAS)
The Krackow Activity Scale (KAS) lower extremity activity scale.
Radiographic Analysis
AP long standing X-ray
Determine degree of Varus or Valgus

Full Information

First Posted
June 25, 2015
Last Updated
August 14, 2023
Sponsor
Medacta USA
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1. Study Identification

Unique Protocol Identification Number
NCT02501733
Brief Title
Medacta GMK Sphere® Multicenter Post-Market Outcomes Study
Official Title
Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medacta USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total Knee Replacement, Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medacta GMK Sphere® Knee Prosthesis
Arm Type
Other
Arm Description
All subjects enrolled will receive the Medacta GMK Sphere® Medial Knee Prosthesis
Intervention Type
Device
Intervention Name(s)
Medacta GMK Sphere® Medial Knee Prosthesis
Other Intervention Name(s)
Total Knee Arthroplasty, Total Knee Prosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively.
Description
Knee function-patients ability to forget the artificial joint in everyday life.
Time Frame
Baseline, 2 and 5 year time points
Secondary Outcome Measure Information:
Title
Total Knee Society Score (KSS)
Description
Total Knee Society score questionnaire to assess pain and function
Time Frame
Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.
Title
Krackow Activity Scale (KAS)
Description
The Krackow Activity Scale (KAS) lower extremity activity scale.
Time Frame
Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
Title
Radiographic Analysis
Time Frame
Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
Title
AP long standing X-ray
Description
Determine degree of Varus or Valgus
Time Frame
Pre-operative and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients willing to sign the informed consent Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self evaluations. Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery. Patients requiring a primary total knee replacement. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). Patients with intact collateral ligaments. Exclusion Criteria: Patients with inflammatory arthritis. Patients that are morbidly obese, body mass index (BMI) > 40. Patients with a history of total or unicompartmental reconstruction of the affected joint. Patients that have had a high tibial osteotomy or femoral osteotomy. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. Patients with a systemic or metabolic disorder leading to progressive bone deterioration. Patients that are immunologically compromised, or receiving chronic steroids (> 30 days). Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. Patients with knee fusion to the affected joint. Patients with an active or suspected latent infection in or about the knee joint. Patients that are prisoners.
Facility Information:
Facility Name
Norhtwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
McBride Orthopedic Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Texas Orthopedics
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Spokane Joint Replacement Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

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Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

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