Clinical trial NCT00763386: A Study to Compare the NexGen LPS and LPS-Flex Knee Implants
Official title: Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Osteoarthritis
Keywords: Total Knee Arthroplasty
Osteoarthritis
Knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 331
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test for significant differences in functional outcomes obtained by using a NexGen LPS versus a NexGen LPS-Flex knee implant. Specifically, it is predicted that an increase in postoperative range of motion will be experienced by patients treated with the NexGen LPS-Flex knee implant.

Detailed description: This study will compare the clinical results of the NexGen LPS femoral component with the higher flexion potential of the NexGen LPS-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is postoperative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

Eligibility criteria: Inclusion Criteria:

* Age, 21-80 years
* Sex, Males and females will be included
* BMI less than or equal to 39 and calf-thigh less than or equal to 90 degrees
* Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history.
* Patient is willing and able to cooperate in follow-up therapy.
* Patient exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
* Patient has stable and functional collateral ligaments.
* Patient has potential to perform higher than average range of motion activities.
* Operative side range of motion flexion greater than or equal to 90 degrees.
* Severe knee pain and disability due to degenerative joint disease.
* Patient or patient's legal representative has signed the Informed Consent form.

Exclusion Criteria:

* Previous history of infection in the affected joint.
* Previously failed knee endoprosthesis of any kind.
* Charcot joint disease or other severe neurosensory deficits.
* Previous patellectomy.
* Patient is skeletally immature.
* Grossly insufficient femoral or tibial bone stock.
* Patient is pregnant.
* Varus or valgus deformity greater than 20 degrees.
* Fixed flexion deformity greater than 15 degrees.
* Previous high tibial osteotomy.
* Previous femoral osteotomy.
* Patient is a poor compliance risk - currently treated for ethanol or drug abuse, physical or mental handicap, etc.
* Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.

Primary outcomes:
measure: Postoperative Range of Motion (ROM)
timeFrame: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Secondary outcomes:
measure: Return to Function (RtF) Via Knee Society Score (Modified)
timeFrame: 6 Weeks to 2 Years Post-op, based on on the intervals listed
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Decatur
country: United States
facility: VA Medical Center
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Joint Replacement Surgeons of Indiana
state: Indiana
city: Mooresville
country: United States
facility: The Center for Hip and Knee Surgery
state: Indiana
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Allentown
country: United States
facility: VSAS Orthopaedics
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: Greenville
country: United States
facility: Piedmont Orthopaedic Associates
state: South Carolina
city: Spartanburg
country: United States
facility: Orthopaedic Specialists of Spartanburg
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Orthopaedic Institute
state: Tennessee
city: Galveston
country: United States
facility: Rebecca Sealy Hospital
state: Texas
city: Charlottesville
country: United States
facility: The Rectors and Visitors of the University of Virginia
state: Virginia
city: Montreal
country: Canada
facility: Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
References: