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Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study

Primary Purpose

Osteoarthritis, Osteoarthritis, Knee, Joint Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medacta GMK Sphere® Medial-Pivot Knee Prosthesis
Medacta GMK PS Posterior Stabilized Knee Prosthesis
Sponsored by
David F. Scott, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoarthritis

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 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), excluding inhalers.
  • 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 whose surgery will utilize computer-assisted surgical navigation (CAOS) techniques.
  • Patients whose surgery will utilize minimally invasive surgical techniques.
  • Patients that are prisoners.

Sites / Locations

  • Spokane Joint Replacement Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Medacta GMK Sphere® Medial-Pivot Knee Prosthesis

Medacta GMK PS Posterior Stabilized Knee Prosthesis

Arm Description

Outcomes

Primary Outcome Measures

Forgotten Joint Score (FJS)
The average Forgotten Joint Score (FJS) of those patients receiving the Medacta GMK Sphere® knee prosthesis will be compared with the average FJS of those receiving the Medacta GMK PS knee prosthesis. The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness.

Secondary Outcome Measures

Total Knee Society Score (KSS)
Clinical outcomes will be evaluated via the Knee Society Score (KSS). The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs. Both scores range from 0-100, with a higher score indicating a better outcome.
Lower Extremity Activity Scale (LEAS)
Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS). The LEAS scale range is 1-18, with a higher value indicating a higher level of activity.
Radiographic Analysis
Radiographs will be assessed for radiolucency, migration and subsidence. An AP Longstanding view will be obtained pre-operatively, and at 6 weeks and 1 year post-operatively to determine degree of Varus or Valgus.

Full Information

First Posted
December 11, 2017
Last Updated
September 27, 2021
Sponsor
David F. Scott, MD
Collaborators
Medacta USA
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1. Study Identification

Unique Protocol Identification Number
NCT03391323
Brief Title
Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study
Official Title
Medacta GMK Sphere® Medial-Pivot, Cruciate Substituting vs. Medacta GMK PS Posterior Stabilized Kne vs. OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David F. Scott, MD
Collaborators
Medacta USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is a prospective, randomized comparison of total knee arthroplasty with the Medacta GMK Sphere® knee compared to the Medacta GMK PS knee, with comparison to data from previous trials of similar study design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee, Joint Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medacta GMK Sphere® Medial-Pivot Knee Prosthesis
Arm Type
Other
Arm Title
Medacta GMK PS Posterior Stabilized Knee Prosthesis
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Medacta GMK Sphere® Medial-Pivot Knee Prosthesis
Intervention Type
Device
Intervention Name(s)
Medacta GMK PS Posterior Stabilized Knee Prosthesis
Primary Outcome Measure Information:
Title
Forgotten Joint Score (FJS)
Description
The average Forgotten Joint Score (FJS) of those patients receiving the Medacta GMK Sphere® knee prosthesis will be compared with the average FJS of those receiving the Medacta GMK PS knee prosthesis. The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness.
Time Frame
Change from baseline at 2 years and 5 years post-operative
Secondary Outcome Measure Information:
Title
Total Knee Society Score (KSS)
Description
Clinical outcomes will be evaluated via the Knee Society Score (KSS). The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs. Both scores range from 0-100, with a higher score indicating a better outcome.
Time Frame
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Title
Lower Extremity Activity Scale (LEAS)
Description
Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS). The LEAS scale range is 1-18, with a higher value indicating a higher level of activity.
Time Frame
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Title
Radiographic Analysis
Description
Radiographs will be assessed for radiolucency, migration and subsidence. An AP Longstanding view will be obtained pre-operatively, and at 6 weeks and 1 year post-operatively to determine degree of Varus or Valgus.
Time Frame
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

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 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), excluding inhalers. 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 whose surgery will utilize computer-assisted surgical navigation (CAOS) techniques. Patients whose surgery will utilize minimally invasive surgical techniques. Patients that are prisoners.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Scott, MD
Organizational Affiliation
Spokane Joint Replacement Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spokane Joint Replacement Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes Study

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