Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
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Purpose
The purpose of the study is to assess the long-term performance of the NexGen LPS-Flex Mobile Bearing Knee in the treatment of patients with severe knee pain or degenerative knee disease.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Traumatic Arthritis Avascular Necrosis of the Femoral Condyle Moderate Varus Valgus Flexion Deformities |
Device: NexGen LPS-Flex Mobile Bearing Knee |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee |
- Functional analysis (Knee Scores) [ Time Frame: Group 1 - annual visits for 5 years; Group 2: Pre-op, 6 week, 6 month, and annual for a total of 5 years ] [ Designated as safety issue: No ]
- Radiographic analysis [ Time Frame: Group 1: annual visits for a total of 5 years; Group 2: Pre-op, 6 week, 6 month and annual for a total of 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Follow-up of existing IDE study subjects
|
Device: NexGen LPS-Flex Mobile Bearing Knee
Total Knee Replacement
Other Name: Mobile bearing knee
|
|
2
Newly enrolled study subjects
|
Device: NexGen LPS-Flex Mobile Bearing Knee
Total Knee Replacement
Other Name: Mobile bearing knee
|
Detailed Description:
The NexGen LPS-FLex Mobile Bearing Knee received FDA approval for commercial distribution in the US on December 10, 2007. The approval was in accordance with a "condition of approval" to perform a 10-year post approval study to evaluate the longer-term safety and effectiveness of the LPS-Flex Mobile Bearing Knee. The post approval study will consist of patients from the investigational device exemption study arm (Group 1) as well as patients who are eligible for a total knee replacement and have been chosen to receive the LPS-Flex Mobile Knee (Group 2). Group 1 will be followed through a total of 10 years from the date of surgery. Group 2 will be followed through a total of 5 years from the date of surgery.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Osteoarthritis
- Primary and secondary traumatic arthritis
- Avascular necrosis of the femoral condyle
- Moderate varus, valgus, or flexion deformities (i.e. valgus/varus deformity of less than or equal to 15 degrees, fixed flexion deformity of less than or equal to 10 degrees)
Exclusion Criteria:
- Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint
- Insufficient bone stock on femoral or tibial surfaces
- Skeletal immaturity
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral integrity
- Total knee arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA) and an ulcer of the skin or a history of recurrent breakdown of the skin because their risk of postoperative infection is greater. RA patient using steroids may also have increased risk of infection. Late infections in RA patients have been reported 24+ months postoperative.
- Patient is a poor compliance risk, i.e., history of ethanol or drug abuse, or mental handicap that would compromise patient compliance with respect to rehabilitation or follow-up
- Patient is not willing or able to give informed consent to participate in the follow-up program
- Patient is not willing to return for all scheduled follow-up appointments as defined by this protocol.
Contacts and Locations| Contact: Kim Rowe, BS | 574-372-4843 | kim.rowe@zimmer.com |
| Contact: Kacy Arnold | 574-371-8336 | kacy.arnold@zimmer.com |
| United States, Arizona | |
| Tucson Orthopaedic Institute, PC | Active, not recruiting |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| UC Davis School of Medicine | Terminated |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| Western Orthopaedics | Active, not recruiting |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Phoenix Clinical Research | Recruiting |
| Tamarac, Florida, United States, 33321 | |
| Contact: Steffanie Littleton 954-718-7776 steflitt@bellsouth.net | |
| Principal Investigator: Richard Berkowitz, MD | |
| United States, Idaho | |
| ADA Orthopaedic Clinic | Active, not recruiting |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Mitchell Sheinkop, MD | Active, not recruiting |
| Chicago, Illinois, United States, 60640 | |
| United States, Michigan | |
| Rochester Knee and Sports Medicine, PC | Recruiting |
| Auburn Hills, Michigan, United States, 48236-2776 | |
| Contact: John Olenyn, MD 248-377-8000 | |
| Principal Investigator: John Olenyn, MD | |
| United States, New Jersey | |
| Hartzband Joint Replacement Institute | Active, not recruiting |
| Paramus, New Jersey, United States, 07652 | |
| United States, New York | |
| ISK Institute | Active, not recruiting |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| OrthoCarolina Research Institute | Active, not recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| United States, Tennessee | |
| Tennessee Orthopaedic Foundation for Education and Research | Recruiting |
| Knoxville, Tennessee, United States, 37923 | |
| Contact: Jane Smith 865-373-1811 smithjo@tocdocs.com | |
| Principal Investigator: Harold Cates, Jr., MD | |
| Canada, Manitoba | |
| Concordia Joint Replacement Group | Active, not recruiting |
| Winnipeg, Manitoba, Canada, R2K 2M9 | |
More Information
No publications provided
| Responsible Party: | Zimmer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00854295 History of Changes |
| Other Study ID Numbers: | 07-100 |
| Study First Received: | February 26, 2009 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Zimmer, Inc.:
|
arthritis osteoarthritis degenerative knee disease |
avascular necrosis total knee replacement TKA |
Additional relevant MeSH terms:
|
Congenital Abnormalities Arthritis Necrosis Osteonecrosis Osteoarthritis |
Joint Diseases Musculoskeletal Diseases Pathologic Processes Bone Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013