Clinical trial NCT00854295: Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Official title: Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Traumatic Arthritis
Avascular Necrosis of the Femoral Condyle
Moderate Varus
Valgus
Flexion Deformities
Keywords: arthritis
osteoarthritis
degenerative knee disease
avascular necrosis
total knee replacement
TKA
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2009-03-03
Enrollment: 266
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 from 4 years through a total of 10 years from the date of surgery. Group 2 will be followed from pre-op through a total of 5 years from the date of surgery.

Eligibility criteria: 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.

Primary outcomes:
measure: Group 2 - Total Knee Society Score (KSS)
timeFrame: Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
measure: Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss
timeFrame: 5 year
measure: Group 2 - Number of Subjects With Absence of Implant Revision
timeFrame: 5 year
measure: Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication
timeFrame: 5 year
measure: Group 1 - Total Knee Society Score (KSS)
timeFrame: 4 year, 5 year, 6 year, 8 year, and 10 year
measure: Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss
timeFrame: 10 year
measure: Group 1 - Number of Subjects With Absence of Implant Revision
timeFrame: 10 year
measure: Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tamarac
country: United States
facility: Phoenix Clinical Research
state: Florida
city: Auburn Hills
country: United States
facility: Advanced Orthopaedics
state: Michigan
city: Knoxville
country: United States
facility: Tennessee Orthopaedic Foundation for Education and Research
state: Tennessee
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References: