LPS Flex Porous Femoral Components

NCT01462240 | Withdrawn

• 1 other identifier: CMU2010-27K
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Poly Arthritis; Collagen Disorders; Avascular Necrosis of Femoral Condyle

Keywords

arthritis

Outcome Measures

Primary Outcomes (1)

• Survivorship

  Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse device effects and unanticipated adverse device effects or removal of the device summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence intervals.

  10 Years

Secondary Outcomes (1)

• Pain and Functional Performance

  10 years

Study Arms (1)

1 - LPS Flex Pororus Femoral Components

Patients suffering from severe knee pain and disability.

Device: LPS Flex Porous Femoral Components

Interventions

LPS Flex Porous Femoral Components DEVICE

Porous femoral components in total knee arthroplasty

1 - LPS Flex Pororus Femoral Components

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Each investigator will screen from this patient populatin patients suffering from severe knee pain and disability who meet the inclusion/exclusion criteria for study participation.

You may qualify if:

• Patient 18-75 years of age, inclusive;
• Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle;
• Post-Traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• Moderate valgus, varus, or flexion deformities;
• Patient has undergone a study related informed consent process;
• Patient is willing and able to provide written consent;
• Patient is willing and able to cooperate in the required post-operative therapy;
• Patient is willing and able to complete scheduled follow-up evaluations.

You may not qualify if:

• Patient has previous history of infection in the affected joint and/or a local or systemic infection that could 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;
• Stable, painless arthrodesis in a satisfactory functional position;
• Severe instability secondary to the absence of collateral ligament integrity;
• Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
• Patient has a known sensitivity or allergy to one or more of the implanted materials;
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Collagen Diseases; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kacy Arnold, RN, MBA

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 31, 2011
• Study Start: May 20, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share