Total Knee Arthroplasty Comparing Cementless to Cemented Fixation

Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Cementless (Nexgen); Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cementless Nexgen CR; Cementless fixation of Nexgen CR TKR	Device: Cementless (Nexgen); Cementless fixation of Nexgen CR TKR; Other Names: Cementless Nexgen
Active Comparator: Cemented Nexgen CR; Cemented fixation of Nexgen CR TKR	Device: Cemented (Nexgen); Cemented fixation of Nexgen CR TKR; Other Names: Cemented Nexgen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Knee Society Knee Score	change in knee score will be compared with initial score, until mean follow up of 25 years.	Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in the Range of Motion	change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 25 years.	Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Collaborators and Investigators

• Sponsor: Young Hoo Kim
• Investigators: Principal Investigator: Jang Won Park, MD, Ewha Womans University Mokdong Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Primary Completion (Actual): February 1, 1998
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: total knee arthroplasty; cemented; cementless; fixation; posterior stabilized; cruciate retaining
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: TKRcementless