search
Back to results

Mobile - Bearing Knee Study

Primary Purpose

Inflammatory Tissue Disorder, Osteoarthritis, Avascular Necrosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Encore Mobile-Bearing Knee
Sponsored by
Encore Medical, L.P.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Tissue Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Carl T. Hayden VA Hospital
  • Orange Coast Memorial Medical Center
  • S.Florida VA Found. For Research & Education, Inc.
  • Great Lakes Orthopaedics
  • Orthopedic Surgery Center and Sports Medicine
  • The Orthopedic Specialty Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study.

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2008
Last Updated
May 10, 2011
Sponsor
Encore Medical, L.P.
search

1. Study Identification

Unique Protocol Identification Number
NCT00765362
Brief Title
Mobile - Bearing Knee Study
Official Title
Encore Mobile - Bearing Knee Study #200
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Encore Medical, L.P.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Tissue Disorder, Osteoarthritis, Avascular Necrosis, Post-traumatic Arthritis, Secondary Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study.
Intervention Type
Device
Intervention Name(s)
Encore Mobile-Bearing Knee
Other Intervention Name(s)
MBK
Intervention Description
Used for primary total knee replacement
Primary Outcome Measure Information:
Title
Knee Society Score Evaluation
Description
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).
Time Frame
2 year
Title
Knee Society Function Score
Description
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.
Time Frame
2 year
Title
Knee Society Scores Used as Success/Failure Criteria.
Description
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.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Carl T. Hayden VA Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Orange Coast Memorial Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
S.Florida VA Found. For Research & Education, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Great Lakes Orthopaedics
City
Garden City
State/Province
Michigan
ZIP/Postal Code
48135
Country
United States
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926
Country
United States
Facility Name
Orthopedic Surgery Center and Sports Medicine
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
The Orthopedic Specialty Hospital
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84084
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.djosurgical.com
Description
Sponsor company home page

Learn more about this trial

Mobile - Bearing Knee Study

We'll reach out to this number within 24 hrs