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Phase 4 N=70 Randomized Treatment

Knee Arthroplasty Performed With Conventional and Customized Instrumentation

Knee Arthritis

Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Length of Surgery — 3447.19; 3707.19 seconds

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Customized Patient Instrumentation (Device); Traditional Instrumentation (Device)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
Anderson Orthopaedic Research Institute
Primary completion
Jul 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Length of Surgery
3447.19; 3707.19
SECONDARY
Length of Each Surgical Step (in Seconds)
297.19; 318.38; 111.77; 129.73; 95.19; 170.46
SECONDARY
Number of Instrument Trays Required
7.3; 2.5
SECONDARY
Limb Alignment (Mechanical Axis)
0.7; 0.3

Summary

The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other. The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.

Eligibility Criteria

Inclusion Criteria

  • Patient requires unilateral primary total knee arthroplasty

Exclusion Criteria

  • Body mass index greater than 41
  • Previous ipsilateral hip or ankle replacement
  • Knee flexion contracture greater than 20 degrees
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01124305). 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.

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