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Completed

NCT Number: NCT00837447

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee replacement with NexGen CR knee prosthesis

Device

comparison of functional outcome in patients receiving either NexGen posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis

Other names: NexGen CR

Total knee replacement(TKR) with Nexgen CR-flex

Device

TKR using Nexgen CR-flex implant

Other names: Nexgen CR-flex

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses A Prospective, Randomized Study

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 5, 2009
Registry last updated
Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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