Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

NCT02501733 | Completed

• 1 other identifier: 121416-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoarthritis

Keywords

Total Knee Replacement; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Knee Society Score (KSS)

  Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.

• Krackow Activity Scale (KAS)

  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

  Pre-operative and 6 weeks

Study Arms (1)

Medacta GMK Sphere® Knee Prosthesis

OTHER

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

Device: Medacta GMK Sphere® Medial Knee Prosthesis

Interventions

Medacta GMK Sphere® Medial Knee Prosthesis DEVICE

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.

Also known as: Total Knee Arthroplasty, Total Knee Prosthesis

Medacta GMK Sphere® Knee Prosthesis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medacta USA: lead

Study Sites (5)

Norhtwestern University

Chicago, Illinois, 60611, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

McBride Orthopedic Hospital

Oklahoma City, Oklahoma, 73103, United States

Location

Texas Orthopedics

Austin, Texas, 78759, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 17, 2015
• Study Start: June 1, 2015
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (5)