Clinical trial NCT00733486: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 233
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: Pre-op to 3 months
measure: Change from baseline to 1 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score
timeFrame: Pre-op to 1 year
measure: Change from baseline to 3 year post-operative assessment in clinical outcome (stability, pain, range of motion and function) using the American Society Score
timeFrame: Pre-op to 3 years
measure: Incidence of anterior knee pain and patellar function using the Patellar Score
timeFrame: 3 months post-operatively
measure: Incidence of anterior knee pain and patellar function using the Patellar Score
timeFrame: 1 year post-operatively
measure: Incidence of anterior knee pain and patellar function using the Patellar Score
timeFrame: 3 year post-operatively
measure: Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
timeFrame: 3 months post-operatively
measure: Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
timeFrame: 1 year post-operatively
measure: Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
timeFrame: 3 years post-operatively
measure: Patient derived outcome in terms of general quality of life, as determined by the SF-12
timeFrame: 3 months post-operatively
measure: Patient derived outcome in terms of general quality of life, as determined by the SF-12
timeFrame: 1 year post-operatively
measure: Patient derived outcome in terms of general quality of life, as determined by the SF-12
timeFrame: 3 years post-operatively
measure: A survival analysis of the LCS Complete AP Glide knee prosthesis
timeFrame: 1 year post-operatively
measure: A survival analysis of the LCS Complete AP Glide knee prosthesis
timeFrame: 3 years post-operatively
measure: Assessment of component alignment and positioning
timeFrame: 3 months post-operatively
measure: Assessment of component alignment and positioning
timeFrame: 1 year post-operatively
measure: Assessment of component alignment and positioning
timeFrame: 3 years post-operatively
measure: Assessment of radiolucencies
timeFrame: 3 months post-operatively
measure: Assessment of radiolucencies
timeFrame: 1 year post-operatively
measure: Assessment of radiolucencies
timeFrame: 3 years post-operatively
measure: Assessment of Patella Tilt and patellofemoral alignment
timeFrame: 3 months, 1 yr, and 3 yrs
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Dong-A University medical centre
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yongsei University College of Medicine
Study officials:
References: