A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee

A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (AP Glide) Mobile Bearing Knee System in Primary Knee Arthroplasty

The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years.

The secondary objectives of this investigation are to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: L.C.S. APG Knee Anterior Posterior Glide knee

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Dong-A University medical centre
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital, Yongsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects, aged between 45 and 85 years inclusive.
• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
• Subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
• Subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments.
• Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the LCS Complete AP Glide mobile bearing knee system, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

• Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• Revision of an existing knee implant (including unicompartmental implants).
• Female subjects who are pregnant.
• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
• Subjects who have participated in a clinical study with an investigational product in the last month (30 days).
• Subjects who are currently involved in any personal injury litigation claims.
• Subjects involved in personal Medical-Legal claims.
• Subjects with a known history of poor compliance to medical treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: L.C.S. APG Knee Anterior Posterior Glide knee; Orthopaedic implant for primary knee replacement	Device: L.C.S. APG Knee Anterior Posterior Glide knee; Orthopaedic implant for primary knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline to 3 months post-operative assessment in:Clinical outcome (stability, pain, range of motion and function), using the American Knee Society Score.	American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee	Pre-op to 3 months
Change from baseline to 1 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score	American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee	Pre-op to 1 year
Change from baseline to 3 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score	American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee	Pre-op to 3 years
Incidence of anterior knee pain and patellar function using the Patellar Score	The Patellar Score is a 1 to 30 point outcome score (where 30 indicates the best outcome) that evaluates the patella of the affected knee. The patellar score is composed of Anterior Knee Pain (max 15 points), Quadriceps Strength (max 5 points), Ability to rise from chair (max 5 points), and Stair-climbing (max 5 points).	3 months post-operatively
Incidence of anterior knee pain and patellar function using the Patellar Score	The Patellar Score is a 1 to 30 point outcome score (where 30 indicates the best outcome) that evaluates the patella of the affected knee. The patellar score is composed of Anterior Knee Pain (max 15 points), Quadriceps Strength (max 5 points), Ability to rise from chair (max 5 points), and Stair-climbing (max 5 points).	1 year post-operatively
Incidence of anterior knee pain and patellar function using the Patellar Score	The Patellar Score is a 1 to 30 point outcome score (where 30 indicates the best outcome) that evaluates the patella of the affected knee. The patellar score is composed of Anterior Knee Pain (max 15 points), Quadriceps Strength (max 5 points), Ability to rise from chair (max 5 points), and Stair-climbing (max 5 points).	3 year post-operatively
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score	The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.	3 months post-operatively
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score	The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.	1 year post-operatively
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score	The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.	3 years post-operatively
Patient derived outcome in terms of general quality of life, as determined by the SF-12	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality.	3 months post-operatively
Patient derived outcome in terms of general quality of life, as determined by the SF-12	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality.	1 year post-operatively
Patient derived outcome in terms of general quality of life, as determined by the SF-12	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality.	3 years post-operatively
A survival analysis of the LCS Complete AP Glide knee prosthesis	Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40* devices are left still being followed.	1 year post-operatively
A survival analysis of the LCS Complete AP Glide knee prosthesis	Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40* devices are left still being followed.	3 years post-operatively
Assessment of component alignment and positioning		3 months post-operatively
Assessment of component alignment and positioning		1 year post-operatively
Assessment of component alignment and positioning		3 years post-operatively
Assessment of radiolucencies		3 months post-operatively
Assessment of radiolucencies		1 year post-operatively
Assessment of radiolucencies		3 years post-operatively
Assessment of Patella Tilt and patellofemoral alignment		3 months, 1 yr, and 3 yrs

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: August 11, 2008
• First Submitted That Met QC Criteria: August 12, 2008
• First Posted (Estimate): August 13, 2008

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CT 02/41