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A Study to Compare the NexGen CR and CR-Flex Knee Implants

Primary Purpose

Total Knee Arthroplasty, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NexGen CR-Flex Fixed Bearing Knee
NexGen CR Knee
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring Total Knee Arthroplasty, Osteoarthritis, Knee

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age, 21-80 years
  • Sex, Male and Females will be included
  • BMI less than or equal to 39
  • Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history.
  • Patient is willing and able to cooperate in follow-up therapy.
  • Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion.
  • Patient has stable and functional posterior cruciate and collateral ligaments.
  • Patient has potential to perform higher than average range of motion activities.
  • Operative side range of motion flexion greater than or equal to 120 degrees.
  • Severe knee pain and disability due to degenerative joint disease.
  • Patient or patient's legal representative has signed the Informed Consent form.

Exclusion Criteria:

  • Previous history of infection in the affected joint.
  • Previously failed knee endoprosthesis of any kind.
  • Charcot joint disease or other severe neurosensory deficits.
  • Previous patellectomy
  • Patient is skeletally immature.
  • Grossly insufficient femoral or tibial bone stock.
  • Patient is pregnant.
  • Varus or valgus deformity greater than 20 degrees.
  • Fixed flexion deformity greater than 15 degrees.
  • Previous high tibial osteotomy.
  • Previous femoral osteotomy.
  • Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc.
  • Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.

Sites / Locations

  • Dickinson Medical Group, LLC
  • University of Chicago Hospital
  • Rockford Orthopedic Associates
  • University of Massachusetts Memorial Medical Center
  • Orthopaedic Associates of Grand Rapids, PC
  • Pinehurst Surgical Center
  • Slocum Orthopedics, PC
  • The Orthopedic Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.

Study arm will consist of patients that are treated with the NexGen CR Knee.

Outcomes

Primary Outcome Measures

Postoperative Range of Motion (ROM)
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.

Secondary Outcome Measures

Return to Function (RtF) Via Knee Scoiety Score (Modified)
Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.

Full Information

First Posted
September 26, 2008
Last Updated
June 12, 2012
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00761956
Brief Title
A Study to Compare the NexGen CR and CR-Flex Knee Implants
Official Title
Prospective Randomized Multicenter Study of NexGen CR-Flex Knee
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test for significant differences in functional outcomes, specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
Detailed Description
This study will compare the clinical results of the NexGen CR femoral component with the higher flexion potential of the NexGen CR-Flex femoral component in all patients with degenerative joint disease that require total knee arthroplasty. The primary variable of interest is post-operative range of motion achieved with the two devices, which are implanted with slightly different surgical techniques in patients who may also be subjected to different rehabilitation programs depending on the device they are assigned.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Osteoarthritis
Keywords
Total Knee Arthroplasty, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Study arm will consist of patients that are treated with the NexGen CR-Flex Fixed Bearing Knee.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Study arm will consist of patients that are treated with the NexGen CR Knee.
Intervention Type
Device
Intervention Name(s)
NexGen CR-Flex Fixed Bearing Knee
Other Intervention Name(s)
CR-Flex Knee
Intervention Description
NexGen CR-Flex Fixed Bearing femoral component
Intervention Type
Device
Intervention Name(s)
NexGen CR Knee
Other Intervention Name(s)
CR Knee
Intervention Description
NexGen Complete Knee Solution Cruciate Retaining femoral component
Primary Outcome Measure Information:
Title
Postoperative Range of Motion (ROM)
Description
The subject will have the operative joint's range of motion/movement assessed through a series of exercises and bends. The assessor will measure how far the joint bends/moves in each direction by degrees. The measurements are taken at each visit interval and recorded.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Return to Function (RtF) Via Knee Scoiety Score (Modified)
Description
Scores were calculated from responses on a modified Knee Society Score by the enrolled subjects for the stated visit intervals. Grading for the Knee Society Score is based on a scale from 0-100 and results are estabalished follows: 80-100 = Excellent; 70-79 = Good; 60-69 = Fair; and Below 60 = Poor.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age, 21-80 years Sex, Male and Females will be included BMI less than or equal to 39 Stable Health, the patient would be able to undergo surgery and participate in a follow-up program based on physical examination and medical history. Patient is willing and able to cooperate in follow-up therapy. Patient exhibits pre-operative radiographic evidenced of joint degeneration consistent with TKA that cannot be treated in non-operative fashion. Patient has stable and functional posterior cruciate and collateral ligaments. Patient has potential to perform higher than average range of motion activities. Operative side range of motion flexion greater than or equal to 120 degrees. Severe knee pain and disability due to degenerative joint disease. Patient or patient's legal representative has signed the Informed Consent form. Exclusion Criteria: Previous history of infection in the affected joint. Previously failed knee endoprosthesis of any kind. Charcot joint disease or other severe neurosensory deficits. Previous patellectomy Patient is skeletally immature. Grossly insufficient femoral or tibial bone stock. Patient is pregnant. Varus or valgus deformity greater than 20 degrees. Fixed flexion deformity greater than 15 degrees. Previous high tibial osteotomy. Previous femoral osteotomy. Patient is a poor compliance risk, currently treated for ethanol or drug abuse, physical or mental handicap, etc. Loss of musculature or absence of musculoligamentous supporting structures required for adequate soft tissue balance.
Facility Information:
Facility Name
Dickinson Medical Group, LLC
City
Milford
State/Province
Delaware
ZIP/Postal Code
19963
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Rockford Orthopedic Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Orthopaedic Associates of Grand Rapids, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Pinehurst Surgical Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Slocum Orthopedics, PC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
The Orthopedic Group
City
Clairton
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States

12. IPD Sharing Statement

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A Study to Compare the NexGen CR and CR-Flex Knee Implants

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