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Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses

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ClinicalTrials.gov Identifier: NCT00837447
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : April 10, 2013
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University

Study Description
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Brief Summary:
The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Total knee replacement with NexGen CR knee prosthesis Device: Total knee replacement(TKR) with Nexgen CR-flex Phase 4

Detailed Description:
The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study
Study Start Date : October 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: NexGen CR knee prosthesis
side of knee operated with total knee replacement with Nexgen CR prosthesis
 Device: Total knee replacement with NexGen CR knee prosthesis
comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis
Other Name: NexGen CR
Active Comparator: NexGen CR-Flex knee prosthesis
side of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis
 Device: Total knee replacement(TKR) with Nexgen CR-flex
TKR using Nexgen CR-flex implant
Other Name: Nexgen CR-flex


Outcome Measures
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Primary Outcome Measures :
  1. Change in Knee Society Knee Score [ Time Frame: baseline and 3 years ]

    change in knee score will be compared with baseline and follow up of 3 years. The knee society knee score range from 0 to 100 points, 100 being the best possible outcome.

    Baseline-NexGen (CR) knee socre:29 points Baseline-NexGen (CR-Flex) knee socre:29 points Follow up of 3 years-NexGen (CR) knee socre: 93.7 points Follow up of 3 years-NexGen (CR-Flex) knee socre: 93.9 points



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria:

  • inflammatory arthritis
  • osteoarthritis of the hip causing pain or restricted mobility
  • a foot or ankle disorder which limited walking
  • dementia or a neurological disorder including a past history of stroke which affected mobility
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837447


Sponsors and Collaborators
Ewha Womans University
Investigators
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Study Director: Young-Hoo Kim, MD Ewha Womans University Mokdong Hospital
More Information
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Responsible Party: Young Hoo Kim, Professor and Director, Ewha Womans University
ClinicalTrials.gov Identifier: NCT00837447    
Other Study ID Numbers: 2007-7
First Posted: February 5, 2009    Key Record Dates
Results First Posted: April 10, 2013
Last Update Posted: April 10, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases