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

• Sponsor: Ewha Womans University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00837447
• Collaborator: (none)
• Enrollment: 54
• Arms: 2
• Duration (Months): 41

Study Details

Study Description

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

• Study Type: Interventional
• 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: Oct 1, 2004
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

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 Names: 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 Names: Nexgen CR-flex

Outcome Measures

Primary Outcome Measures

1. Change in Knee Society Knee Score [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

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Ewha Womans University

Investigators

• Study Director: Young-Hoo Kim, MD, Ewha Womans University Mokdong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Young Hoo Kim, Professor and Director, Ewha Womans University
• ClinicalTrials.gov Identifier: NCT00837447
• Other Study ID Numbers: 2007-7
• First Posted: Feb 5, 2009
• Last Update Posted: Apr 10, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Arm/Group Title	NexGen CR and CR-flex Knee Prosthesis
Arm/Group Description	The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
Period Title: Overall Study
STARTED	54
COMPLETED	54
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	NexGen CR and CR-flex Knee Prosthesis
Arm/Group Description	The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
Overall Participants	54
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 20.4%
>=65 years	43 79.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.7 (6.43)
Sex: Female, Male (Count of Participants)
Female	49 90.7%
Male	5 9.3%
Region of Enrollment (participants) [Number]
Korea, Republic of	54 100%

Outcome Measures

1. Primary Outcome

Title	Change in Knee Society Knee Score
Description	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
Time Frame	baseline and 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High-Flexion Posterior Cruciate Retaining TKA	High-Flexion Posterior Cruciate Scrificing TKA
Arm/Group Description
Measure Participants	54	54
Mean (Standard Deviation) [scores on a scale]	93.9 (4.66)	93.7 (4.53)

Adverse Events

Arm/Group Title	NexGen CR and CR-flex Knee Prosthesis
Arm/Group Description	The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
All Cause Mortality
	NexGen CR and CR-flex Knee Prosthesis
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NexGen CR and CR-flex Knee Prosthesis
	Affected / at Risk (%)	# Events
Total	0/54 (0%)
Other (Not Including Serious) Adverse Events
	NexGen CR and CR-flex Knee Prosthesis
	Affected / at Risk (%)	# Events
Total	0/54 (0%)

Limitations/Caveats

First, the knee scoring system is prone to intraobserver variability. Second, we had no interobserver variability and this could have lead to bias in interpreting radiographic results.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.