Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01335438
First received: April 11, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.


Condition Intervention Phase
Osteoarthritis
Device: Cementless (Nexgen)
Device: Cemented (Nexgen)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Improvement in Knee Society Knee Score [ Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery ] [ Designated as safety issue: No ]
    change in knee score will be compared with initial score, until mean follow up of 25 years.


Secondary Outcome Measures:
  • Improvement in the Range of Motion [ Time Frame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery ] [ Designated as safety issue: No ]
    change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.


Enrollment: 96
Study Start Date: January 1997
Study Completion Date: March 2011
Primary Completion Date: February 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cementless Nexgen CR
Cementless fixation of Nexgen CR TKR
Device: Cementless (Nexgen)
Cementless fixation of Nexgen CR TKR
Other Name: Cementless Nexgen
Active Comparator: Cemented Nexgen CR
Cemented fixation of Nexgen CR TKR
Device: Cemented (Nexgen)
Cemented fixation of Nexgen CR TKR
Other Name: Cemented Nexgen

Detailed Description:

Out comes measures were to determine:

  1. whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
  2. whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
  3. whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
  4. whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.
  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335438

Locations
Korea, Republic of
Ewha Womans University Mokdong Hosptial
Seoul, Korea, Republic of
Sponsors and Collaborators
Young Hoo Kim
Investigators
Principal Investigator: Jang Won Park, MD Ewha Womans University Mokdong Hospital
  More Information

No publications provided

Responsible Party: Young Hoo Kim, Professor and Director, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01335438     History of Changes
Other Study ID Numbers: TKRcementless
Study First Received: April 11, 2011
Last Updated: October 4, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
total knee arthroplasty
cemented
cementless
fixation
posterior stabilized
cruciate retaining

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014