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

NCT00854295 | Completed Results FDA Device

• 1 other identifier: 07-100
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Post-Approval Study Group (Group 2)

EXPERIMENTAL

Subjects enrolled in a short-term study (5 years) consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by orthopedic surgeons experienced in primary total knee replacement. All Group 2 subjects, both unilateral and bilateral subjects, are in the same arm of the study. As part of the PAS study, these subjects were followed from Pre-operative to 5 years.

Device: NexGen LPS-Flex Mobile Bearing Knee

Investigational Device Exemption Group (Group 1)

EXPERIMENTAL

Subjects who were implanted with either the LPS Flex Fixed Bearing Knee (control population) or the LPS Flex Mobile Bearing Knee device during the previous Investigational Device Exemption study. As part of the PAS study, these subjects were followed from 4 years to 10 years.

Device: NexGen LPS-Flex Mobile Bearing Knee

Interventions

NexGen LPS-Flex Mobile Bearing Knee DEVICE

Total Knee Replacement

Also known as: Mobile bearing knee

Investigational Device Exemption Group (Group 1); Post-Approval Study Group (Group 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Phoenix Clinical Research

Tamarac, Florida, 33321, United States

Location

Advanced Orthopaedics

Auburn Hills, Michigan, 48236-2776, United States

Location

Tennessee Orthopaedic Foundation for Education and Research

Knoxville, Tennessee, 37923, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Genu Valgum; Arthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Erin Osborn
• Organization: Zimmer Biomet

erin.osborn@zimmerbiomet.com

574-371-9884

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 3, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 14, 2023
• Results First Posted: February 14, 2023

Record last verified: 2023-01

Locations

US (3)