Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02501733
• Other study ID #: 121416-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Medacta USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Orthopedics	Austin	Texas
United States	Norhtwestern University	Chicago	Illinois
United States	Tulane University	New Orleans	Louisiana
United States	McBride Orthopedic Hospital	Oklahoma City	Oklahoma
United States	Spokane Joint Replacement Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Medacta USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Radiographic Analysis		Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years
Secondary	AP long standing X-ray	Determine degree of Varus or Valgus	Pre-operative and 6 weeks