OsteoarthritisPhase 4NCT00733486

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

A Phase 4 study testing L.C.S. APG Knee Anterior Posterior Glide knee in people with Osteoarthritis, run by DePuy International at 3 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 45 to 85 years
Conditions the study is for: Osteoarthritis
What is being tested?: L.C.S. APG Knee Anterior Posterior Glide knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 3 sitesSouth Korea
Study dates: Aug 2005to Feb 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

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

Other trials in South Korea

About this study

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

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.

Conditions: Osteoarthritis
Being tested: L.C.S. APG Knee Anterior Posterior Glide knee
Keywords: Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L.C.S. APG Knee Anterior Posterior Glide kneeDevice
Orthopaedic implant for primary knee replacement

Study groups in NCT00733486
Study group	Role	What they receive
L.C.S. APG Knee Anterior Posterior Glide knee	Other	Orthopaedic implant for primary knee replacement Receives: Device: L.C.S. APG Knee Anterior Posterior Glide knee

What is being measured

The primary outcome is the main question the study is designed to answer.

A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
Measured: 2 years

Secondary outcomes (21)

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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years post-operatively
Assessment of component alignment and positioning
Measured: 3 months post-operatively
Assessment of component alignment and positioning
Measured: 1 year post-operatively
Assessment of component alignment and positioning
Measured: 3 years post-operatively
Assessment of radiolucencies
Measured: 3 months post-operatively
Assessment of radiolucencies
Measured: 1 year post-operatively
Assessment of radiolucencies
Measured: 3 years post-operatively
Assessment of Patella Tilt and patellofemoral alignment
Measured: 3 months, 1 yr, and 3 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2005Feb 2011

First posted13 Aug 2008 (estimated)
Study startAug 2005
Primary completionDec 2010
Study completionFeb 2011

Why it stopped: The study was terminated at 2 years as investigators were unable to continue participation in the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00733486
Sponsor's protocol ID: CT 02/41
Status last verified: Jun 2015
First submitted: 11 Aug 2008
Last updated: 9 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00733486
Acronym / sponsor ID: CT 02/41
Conditions: Osteoarthritis
Keywords: Arthroplasty, Replacement, Knee, LCS Complete APG (MeSH);
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated at 2 years as investigators were unable to continue participation in the study.
Enrolment: 233 participants (actual)
Lead sponsor: DePuy InternationalIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Dec 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 13 Aug 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
L.C.S. APG Knee Anterior Posterior Glide knee	Other	Device: L.C.S. APG Knee Anterior Posterior Glide kneeOrthopaedic implant for primary knee replacement

Who may qualify

Ages: 45 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L.C.S. APG Knee Anterior Posterior Glide kneeOrthopaedic implant for primary knee replacement	Device	L.C.S. APG Knee Anterior Posterior Glide knee

Primary outcome

A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years.
Time frame: 2 years

21 secondary outcomes

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.
Time frame: 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
Time frame: 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
Time frame: Pre-op to 3 years
Incidence of anterior knee pain and patellar function using the Patellar Score
Time frame: 3 months post-operatively
Incidence of anterior knee pain and patellar function using the Patellar Score
Time frame: 1 year post-operatively
Incidence of anterior knee pain and patellar function using the Patellar Score
Time frame: 3 year post-operatively
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
Time frame: 3 months post-operatively
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
Time frame: 1 year post-operatively
Patient derived outcome in terms of joint specific quality of life, as determined by the Oxford Knee Score
Time frame: 3 years post-operatively
Patient derived outcome in terms of general quality of life, as determined by the SF-12
Time frame: 3 months post-operatively
Patient derived outcome in terms of general quality of life, as determined by the SF-12
Time frame: 1 year post-operatively
Patient derived outcome in terms of general quality of life, as determined by the SF-12
Time frame: 3 years post-operatively
A survival analysis of the LCS Complete AP Glide knee prosthesis
Time frame: 1 year post-operatively
A survival analysis of the LCS Complete AP Glide knee prosthesis
Time frame: 3 years post-operatively
Assessment of component alignment and positioning
Time frame: 3 months post-operatively
Assessment of component alignment and positioning
Time frame: 1 year post-operatively
Assessment of component alignment and positioning
Time frame: 3 years post-operatively
Assessment of radiolucencies
Time frame: 3 months post-operatively
Assessment of radiolucencies
Time frame: 1 year post-operatively
Assessment of radiolucencies
Time frame: 3 years post-operatively
Assessment of Patella Tilt and patellofemoral alignment
Time frame: 3 months, 1 yr, and 3 yrs

Results and safety

The study was stopped early (reason given: The study was terminated at 2 years as investigators were unable to continue participation in the study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.

Related trials for Osteoarthritis

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing L.C.S. APG Knee Anterior Posterior Glide knee in people with Osteoarthritis, run by DePuy International at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated at 2 years as investigators were unable to continue participation in the study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.