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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00733486
• Other study ID #: CT 02/41
• Status: Terminated
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: June 8, 2015
• Start date: August 2005
• Est. completion date: February 2011

Study information

• Verified date: June 2015
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 233
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• L.C.S. APG Knee Anterior Posterior Glide knee
Orthopaedic implant for primary knee replacement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.		2 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Assessment of component alignment and positioning		3 months post-operatively	No
Secondary	Assessment of component alignment and positioning		1 year post-operatively	No
Secondary	Assessment of component alignment and positioning		3 years post-operatively	No
Secondary	Assessment of radiolucencies		3 months post-operatively	No
Secondary	Assessment of radiolucencies		1 year post-operatively	No
Secondary	Assessment of radiolucencies		3 years post-operatively	No
Secondary	Assessment of Patella Tilt and patellofemoral alignment		3 months, 1 yr, and 3 yrs	No