Phase 4 N=54 Randomized Double-blind Treatment

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

Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT00837447 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcome: Primary: Change in Knee Society Knee Score — 93.9; 93.7 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Total knee replacement with NexGen CR knee prosthesis (Device); Total knee replacement(TKR) with Nexgen CR-flex (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Ewha Womans University
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Knee Society Knee Score	93.9; 93.7	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00837447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.