Phase 3 N=64 Randomized Single-blind Treatment

Preoperative Alignment of Total Knee Replacement

Knee Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT01242085 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcome: Primary: Alignment of Knee - Measured Mechanical Axis From CT Data — -1.7; -1.3 degrees

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: trumatch group (Procedure); control group (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Palo Alto Health Care System
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Alignment of Knee - Measured Mechanical Axis From CT Data	-1.7; -1.3	—
SECONDARY Surgical Time	4.0; 0	—

Summary

The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.

Eligibility Criteria

Inclusion Criteria:patients undergoing primary total knee replacement - Exclusion Criteria:patients who have hardware involving the hip, knee or ankle -

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Data sourced from ClinicalTrials.gov (NCT01242085). 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.