Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis
• Interventions: Device: Medacta GMK Sphere® Medial Knee Prosthesis

• Registration Number: NCT02501733
• Lead Sponsor: Medacta USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	Baseline, 2 and 5 year time points	Knee function-patients ability to forget the artificial joint in everyday life.

Secondary Outcome Measures

Name	Time	Method
Total Knee Society Score (KSS)	Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.	Total Knee Society score questionnaire to assess pain and function
Krackow Activity Scale (KAS)	Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years	The Krackow Activity Scale (KAS) lower extremity activity scale.
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	Determine degree of Varus or Valgus

Trial Locations

Locations (5)

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Norhtwestern University; 🇺🇸 Chicago, Illinois, United States

McBride Orthopedic Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States

Texas Orthopedics; 🇺🇸 Austin, Texas, United States

Spokane Joint Replacement Center; 🇺🇸 Spokane, Washington, United States