A Study to Compare the NexGen LPS and LPS-Flex Knee Implants

Osteoarthritis Clinical Trial

Official title:

Prospective Randomized Multicenter Study of NexGen LPS-Flex Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763386
• Other study ID #: 00-500
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: May 25, 2012
• Start date: June 2001
• Est. completion date: March 2010

Study information

• Verified date: May 2012
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Total Knee Arthroplasty

Intervention

Device:
• NexGen LPS-Flex Fixed Bearing Knee
NexGen LPS-Flex Fixed Bearing femoral component
• NexGen Legacy Posterior Stabilized Knee
NexGen Legacy Posterior Stabilized femoral component

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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