Back to resultsA Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
L.C.S. APG Knee Anterior Posterior Glide knee
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);
Eligibility Criteria
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.
Sites / Locations
- Dong-A University medical centre
- Ewha Womans University Mokdong Hospital
- Severance Hospital, Yongsei University College of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
L.C.S. APG Knee Anterior Posterior Glide knee
Arm Description
Orthopaedic implant for primary knee replacement
Outcomes
Primary Outcome Measures
A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
Secondary Outcome Measures
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
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
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
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Assessment of component alignment and positioning
Assessment of component alignment and positioning
Assessment of component alignment and positioning
Assessment of radiolucencies
Assessment of radiolucencies
Assessment of radiolucencies
Assessment of Patella Tilt and patellofemoral alignment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00733486
Brief Title
A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated at 2 years as investigators were unable to continue participation in the study.
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
233 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L.C.S. APG Knee Anterior Posterior Glide knee
Arm Type
Other
Arm Description
Orthopaedic implant for primary knee replacement
Intervention Type
Device
Intervention Name(s)
L.C.S. APG Knee Anterior Posterior Glide knee
Intervention Description
Orthopaedic implant for primary knee replacement
Primary Outcome Measure Information:
Title
A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Pre-op to 3 months
Title
Change from baseline to 1 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score
Description
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
Time Frame
Pre-op to 1 year
Title
Change from baseline to 3 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score
Description
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
Time Frame
Pre-op to 3 years
Title
Incidence of anterior knee pain and patellar function using the Patellar Score
Description
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).
Time Frame
3 months post-operatively
Title
Incidence of anterior knee pain and patellar function using the Patellar Score
Description
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).
Time Frame
1 year post-operatively
Title
Incidence of anterior knee pain and patellar function using the Patellar Score
Description
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).
Time Frame
3 year post-operatively
Title
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
Description
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.
Time Frame
3 months post-operatively
Title
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
Description
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.
Time Frame
1 year post-operatively
Title
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
Description
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.
Time Frame
3 years post-operatively
Title
Patient derived outcome in terms of general quality of life, as determined by the SF-12
Description
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.
Time Frame
3 months post-operatively
Title
Patient derived outcome in terms of general quality of life, as determined by the SF-12
Description
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.
Time Frame
1 year post-operatively
Title
Patient derived outcome in terms of general quality of life, as determined by the SF-12
Description
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.
Time Frame
3 years post-operatively
Title
A survival analysis of the LCS Complete AP Glide knee prosthesis
Description
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.
Time Frame
1 year post-operatively
Title
A survival analysis of the LCS Complete AP Glide knee prosthesis
Description
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.
Time Frame
3 years post-operatively
Title
Assessment of component alignment and positioning
Time Frame
3 months post-operatively
Title
Assessment of component alignment and positioning
Time Frame
1 year post-operatively
Title
Assessment of component alignment and positioning
Time Frame
3 years post-operatively
Title
Assessment of radiolucencies
Time Frame
3 months post-operatively
Title
Assessment of radiolucencies
Time Frame
1 year post-operatively
Title
Assessment of radiolucencies
Time Frame
3 years post-operatively
Title
Assessment of Patella Tilt and patellofemoral alignment
Time Frame
3 months, 1 yr, and 3 yrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dong-A University medical centre
City
Pusan
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yongsei University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee
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