Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

Osteoarthritis Clinical Trial

Official title:

Prospective Multicenter Post Approval Study of the LPS-Flex Mobile Bearing Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854295
• Other study ID #: 07-100
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: June 2021

Study information

• Verified date: January 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: June 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis of the Femoral Condyle
• Flexion Deformities
• Moderate Varus
• Necrosis
• Osteoarthritis
• Traumatic Arthritis
• Valgus

Intervention

Device:
• NexGen LPS-Flex Mobile Bearing Knee
Total Knee Replacement

Locations

Country	Name	City	State
United States	Advanced Orthopaedics	Auburn Hills	Michigan
United States	Tennessee Orthopaedic Foundation for Education and Research	Knoxville	Tennessee
United States	Phoenix Clinical Research	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Group 2 - Total Knee Society Score (KSS)	Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.	Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
Primary	Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss	Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."	5 year
Primary	Group 2 - Number of Subjects With Absence of Implant Revision	Revision is defined as "No intended, actual, or planned removal of any component of the knee system."	5 year
Primary	Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication	All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.	5 year
Primary	Group 1 - Total Knee Society Score (KSS)	Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.	4 year, 5 year, 6 year, 8 year, and 10 year
Primary	Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss	Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."	10 year
Primary	Group 1 - Number of Subjects With Absence of Implant Revision	Revision is defined as "No intended, actual, or planned removal of any component of the knee system."	10 year
Primary	Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication	All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.	10 year