Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01797731 · ClinicalTrials.gov registry record · NA
Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty
A NA study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT01797731: Completed NA study, sponsored by Hospital for Special Surgery, New York.
NCT01797731 is a NA study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01797731, a NA study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.
Primary Outcome
The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.
Interventions
- DEVICE Digital hand-held surgical navigation system
- DEVICE Conventional tibial extramedullary alignment system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-09-16 |
| Phase | NA |
What the finished NCT01797731 record still lists
NCT01797731 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Digital hand-held surgical navigation system is the first listed.
NCT01797731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01797731 about?
NCT01797731 is a clinical study titled "Conventional Alignment System Versus Surgical Navigation System in Total Knee Arthroplasty". This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) ...
What is the current status of trial NCT01797731?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2010-12. Estimated completion is 2013-09-16.
What interventions are being tested in trial NCT01797731?
The interventions under investigation include: Digital hand-held surgical navigation system (DEVICE), Conventional tibial extramedullary alignment system (DEVICE).
Who is sponsoring clinical trial NCT01797731?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01797731's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia