Mobile - Bearing Knee Study
This study has been completed.
Sponsor:
Encore Medical, L.P.
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00765362
First received: September 30, 2008
Last updated: May 10, 2011
Last verified: May 2011
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Purpose
To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
| Condition | Intervention | Phase |
|---|---|---|
|
Inflammatory Tissue Disorder Osteoarthritis Avascular Necrosis Post-traumatic Arthritis Secondary Arthritis |
Device: Encore Mobile-Bearing Knee |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Encore Mobile - Bearing Knee Study #200 |
Resource links provided by NLM:
Further study details as provided by Encore Medical, L.P.:
Primary Outcome Measures:
- Knee Society Score Evaluation [ Time Frame: 2 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 419 |
| Study Start Date: | January 2000 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study.
|
Device: Encore Mobile-Bearing Knee
Used for primary total knee replacement
Other Name: MBK
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765362
Locations
| United States, Arizona | |
| Carl T. Hayden VA Hospital | |
| Phoenix, Arizona, United States, 85012 | |
| United States, California | |
| Orange Coast Memorial Medical Center | |
| Fountain Valley, California, United States, 92708 | |
| United States, Florida | |
| S.Florida VA Found. For Research & Education, Inc. | |
| Miami, Florida, United States, 33125 | |
| United States, Michigan | |
| Great Lakes Orthopaedics | |
| Garden City, Michigan, United States, 48135 | |
| United States, South Carolina | |
| Hilton Head Island, South Carolina, United States, 29926 | |
| United States, Texas | |
| Orthopedic Surgery Center and Sports Medicine | |
| Edinburg, Texas, United States, 78539 | |
| United States, Utah | |
| The Orthopedic Specialty Hospital | |
| Murray, Utah, United States, 84107 | |
| West Jordan, Utah, United States, 84084 | |
Sponsors and Collaborators
Encore Medical, L.P.
More Information
Additional Information:
No publications provided
| Responsible Party: | Jane M. Jacob Ph.D., DJO Surgical |
| ClinicalTrials.gov Identifier: | NCT00765362 History of Changes |
| Other Study ID Numbers: | Study 200 |
| Study First Received: | September 30, 2008 |
| Results First Received: | June 16, 2010 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Necrosis Osteonecrosis Osteoarthritis Joint Diseases |
Musculoskeletal Diseases Pathologic Processes Bone Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013