Osteoarthritis
Conditions
Keywords
Total Knee Replacement, Total Knee Arthroplasty
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.
Interventions
DEVICEMedacta 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.
Sponsors
Medacta USA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed