Osteoarthritis Clinical Trial
Official title:
Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee
Verified date | May 2012 |
Source | Zimmer, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 331 |
Est. completion date | March 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Hopital du Sacre-Coeur de Montreal | Montreal | Quebec |
United States | VSAS Orthopaedics | Allentown | Pennsylvania |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | OrthoCarolina Research Institute | Charlotte | North Carolina |
United States | The Rectors and Visitors of the University of Virginia | Charlottesville | Virginia |
United States | VA Medical Center | Decatur | Georgia |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Rebecca Sealy Hospital | Galveston | Texas |
United States | Piedmont Orthopaedic Associates | Greenville | South Carolina |
United States | Joint Replacement Surgeons of Indiana | Indianapolis | Indiana |
United States | The Center for Hip and Knee Surgery | Mooresville | Indiana |
United States | Vanderbilt Orthopaedic Institute | Nashville | Tennessee |
United States | Albert Einstein Healthcare Network | Philadelphia | Pennsylvania |
United States | Orthopaedic Specialists of Spartanburg | Spartanburg | South Carolina |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
Zimmer, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative Range of Motion (ROM) | Postoperative ROM was calculated by taking the measurement of patient flexion minus the measurement of patients' extension. | 6 Weeks to 2 Years Post-op, based on on the intervals listed | No |
Secondary | Return to Function (RtF) Via Knee Society Score (Modified) | Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are established follows: 80-100 =Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor. |
6 Weeks to 2 Years Post-op, based on on the intervals listed | No |
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