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

NCT00837447 | Completed Phase 4 Results

• 1 other identifier: 2007-7
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Knee Society Knee Score

  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

  baseline and 3 years

Study Arms (2)

NexGen CR knee prosthesis

ACTIVE COMPARATOR

side of knee operated with total knee replacement with Nexgen CR prosthesis

Device: Total knee replacement with NexGen CR knee prosthesis

NexGen CR-Flex knee prosthesis

ACTIVE COMPARATOR

side of knee operated with total knee arthroplasty using Nexgen CR-flex prosthesis

Device: Total knee replacement(TKR) with Nexgen CR-flex

Interventions

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

Also known as: NexGen CR

NexGen CR knee prosthesis

Total knee replacement(TKR) with Nexgen CR-flex DEVICE

TKR using Nexgen CR-flex implant

Also known as: Nexgen CR-flex

NexGen CR-Flex knee prosthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and 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.

Results Point of Contact

• Title: Young-Hoo Kim, MD
• Organization: Ewha Womans University School of Medicine

younghookim@ewha.ac.kr

822-26505900

Study Officials

• Young-Hoo Kim, MD

  Ewha Womans University Mokdong Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: October 1, 2004
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 10, 2013
• Results First Posted: April 10, 2013

Record last verified: 2013-03