Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Medacta GMK Sphere® Medial Knee Prosthesis

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Norhtwestern University
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • McBride Orthopedic Hospital
  • Texas
    • Austin, Texas, United States, 78759
      • Texas Orthopedics
  • Washington
    • Spokane, Washington, United States, 99218
      • Spokane Joint Replacement Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: Total Knee Arthroplasty; Total Knee Prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 and 5 year time points

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Knee Society Score (KSS)	Total Knee Society score questionnaire to assess pain and function	Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.
Krackow Activity Scale (KAS)	The Krackow Activity Scale (KAS) lower extremity activity scale.	Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
Radiographic Analysis		Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
AP long standing X-ray	Determine degree of Varus or Valgus	Pre-operative and 6 weeks

Collaborators and Investigators

• Sponsor: Medacta USA
• Investigators: Study Director: Mukesh Ahuja, MBBS, MS, Medacta USA, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimated): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Knee Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 121416-01