Inflammatory Tissue DisorderPhase 3NCT00765362

Mobile - Bearing Knee Study

A Phase 3 study testing Encore Mobile-Bearing Knee in people with Inflammatory Tissue Disorder and Osteoarthritis, run by Encore Medical, L.P. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammatory Tissue Disorder, Osteoarthritis, Avascular Necrosis
What is being tested?: Encore Mobile-Bearing Knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 419 participants
Where: 8 sitesUnited States
Study dates: Jan 2000to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Skeletal maturity
Less than 70 on preoperative Knee Society Score (Rating Score)
Sufficient bone stock, as judged by radiographs, to support primary knee implant
Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
Patient is not pregnant
Primary total knee replacement

Show all 10Show fewer

Sufficient collateral ligaments to support device, as judged by physician during stability testing (varus/valgus and flexion/extension)
Varus deformity <45 or valgus deformity <45 or fixed flexion deformity <90
Patient is likely to be available for evaluation for the duration of the study
Able and willing to sign the informed consent and follow study procedures

Who cannot join

Skeletal immaturity
Greater than or equal to 70 on preoperative Knee Society Score (Rating Scale)
Previous knee surgery that has adversely affected bone stock or prior total knee replacement
Post patellectomy
Patient is pregnant
Insufficient collateral ligaments, as judged by the physician

Show all 11Show fewer

Neurological conditions that might hinder patient's ability to follow study procedures (i.e., any that restrict physical activities such as Parkinson's Disease, Multiple Sclerosis, previous stroke which affects lower extremity).
Varus deformity >45 or valgus deformity >45 or fixed flexion deformity >90.
Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere the with patient's cognitive abilities, senile dementia, and Alzheimer's Disease).
Prisoners
Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Orthopedic Surgery Center and Sports Medicine
Edinburg, Texas, 78539
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708
Great Lakes Orthopaedics
Garden City, Michigan, 48135
Study site
Hilton Head Island, South Carolina, 29926
S.Florida VA Found. For Research & Education, Inc.
Miami, Florida, 33125
The Orthopedic Specialty Hospital
Murray, Utah, 84107
Carl T. Hayden VA Hospital
Phoenix, Arizona, 85012
Study site
West Jordan, Utah, 84084

Other trials in United States

About this study

Official title: Encore Mobile - Bearing Knee Study #200

To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.

Conditions: Inflammatory Tissue Disorder, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis, Secondary Arthritis
Being tested: Encore Mobile-Bearing Knee
Medical subject headings: Osteoarthritis, Osteonecrosis

What participants receive

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

Encore Mobile-Bearing KneeDevice
Also called MBK
Used for primary total knee replacement

Study groups in NCT00765362
Study group	Role	What they receive
1	Experimental	Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study. Receives: Device: Encore Mobile-Bearing Knee

What is being measured

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

Knee Society Score Evaluation
The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
Measured: 2 year
Knee Society Function Score
The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.
Measured: 2 year
Knee Society Scores Used as Success/Failure Criteria.
The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.
Measured: 2 year

Timeline

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

Jan 2000Aug 2008

First posted2 Oct 2008 (estimated)
Study startJan 2000
Primary completionJun 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Inflammatory Tissue DisorderStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 419 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00765362
Sponsor's protocol ID: Study 200
Status last verified: May 2011
First submitted: 30 Sep 2008
Last updated: 11 May 2011
Results posted: Yes, on ClinicalTrials.gov
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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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Encore Mobile - Bearing Knee Study #200
ClinicalTrials.gov ID: NCT00765362
Acronym / sponsor ID: Study 200
Conditions: Inflammatory Tissue Disorder, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis, Secondary Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 419 participants (actual)
Lead sponsor: Encore Medical, L.P.Industry (pharma, biotech, devices)
Study start: Jan 2000
Primary completion: Jun 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 2 Oct 2008 (estimated)
Results: Posted 19 Apr 2011

Clinical summary

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

To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.

Study design

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

Arm	Type	Receives
1	Experimental	Device: Encore Mobile-Bearing KneeSubjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Skeletal maturity
Less than 70 on preoperative Knee Society Score (Rating Score)
Sufficient bone stock, as judged by radiographs, to support primary knee implant
Patients with inflammatory tissue disorders, osteoarthritis, post-traumatic arthritis, secondary arthritis, or avascular necrosis of the femoral condyles
Patient is not pregnant

Key exclusion criteria (11 listed)

Skeletal immaturity
Greater than or equal to 70 on preoperative Knee Society Score (Rating Scale)
Previous knee surgery that has adversely affected bone stock or prior total knee replacement
Post patellectomy
Patient is pregnant

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
Encore Mobile-Bearing KneeAlso: MBKUsed for primary total knee replacement	Device	1

Primary outcome

Knee Society Score Evaluation
Time frame: 2 year
The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
Knee Society Function Score
Time frame: 2 year
The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.
Knee Society Scores Used as Success/Failure Criteria.
Time frame: 2 year
The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.

Results and safety

Results posted to the registry on 19 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Bearing Knee	419	282

Primary outcome: Knee Society Score Evaluation

Time frame: 2 year. Mean (Standard Deviation). Unit: Average Knee Rating Score

Measure	Mobile Bearing Knee n = 173
Value	93.1 (9.9)

Population analysed: Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.

Primary outcome: Knee Society Function Score

Time frame: 2 year. Mean (Standard Deviation). Unit: Average Knee Function Score

Measure	Mobile Bearing Knee n = 173
Value	89.0 (15.6)

Population analysed: Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.

Primary outcome: Knee Society Scores Used as Success/Failure Criteria.

Time frame: 2 year. Number. Unit: Percentage of Participants with Success

Measure	Mobile Bearing Knee n = 173
Knee Society Score Success	91
Knee Function Score Success	84

Population analysed: Out of the 282 subjects who completed the study, only 173 were analyzed due to either the 2 year visit being completed out of window or missing data.

Adverse events

Time frame: Adverse events were collected from the date of surgery through the 2 year visit.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Bearing Knee	0 of 419 (0%)	281 of 419 (67.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sponsor company home pageLink provided by the sponsor.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Encore Mobile-Bearing Knee in people with Inflammatory Tissue Disorder and Osteoarthritis, run by Encore Medical, L.P. at 8 sites in United States.

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 10 inclusion and 11 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: finished, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Knee Society Score Evaluation (time frame: 2 year). The study lists 3 primary outcomes in all. 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 NCT00765362.

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 11 May 2011.