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NCT00733330 · ClinicalTrials.gov registry record · Phase 4

Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study

A Phase 4 study, sponsored by DePuy International.

Terminated
Registry status
Phase 4
Development phase
86
Enrollment target

NCT00733330: Clinical Trial Phase 4 study, sponsored by DePuy International.

NCT00733330 is a Phase 4 study that was terminated before completion, run by DePuy International. The registered enrollment target is 86 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00733330, a Phase 4 study, was terminated before completion, sponsored by DePuy International.

TERMINATED
Registry status
Phase 4
Development phase
86 participants
Enrollment target

Study Summary

The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure. The secondary objectives of this investigation are to: Compare the accuracy of long leg alignment achieved by the two types of procedure. Compare the number of optimal implantations achieved by the two types of procedure. Compare the clinical performance of the knee replacement in subjects who have undergone one of the two types of procedure. Compare the functional outcome achieved by subjects who have undergone one of the two types of procedure. Compare the interface radiographic appearance 5 years post-operatively between the two types of procedure. Compare the accuracy and precision of long leg alignment achieved by the two types of procedure 5 years post-operatively, i.e., at final follow-up and also the change in accuracy and precision between the final follow-up and baseline. Compare the Adverse Events experienced by the subjects who have undergone the two types of procedure.

Primary Outcome

Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)

Interventions

  • DEVICE Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique
  • DEVICE Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2005-01
Est. Completion 2010-12
Phase Phase 4
DePuy International

2 total trials

Why NCT00733330 stopped before completion

NCT00733330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique is the first listed.

NCT00733330 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00733330 about?

NCT00733330 is a clinical study titled "Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study". The primary objective of this investigation is to compare the precision of long leg alignment achieved by the two types of procedure. The secondary objectives of this investigation are to: Compare the accuracy of long leg alignment achieved by the two types of procedure. Compare the number of opti...

What is the current status of trial NCT00733330?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2005-01. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00733330?

The interventions under investigation include: Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique (DEVICE), Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation (DEVICE).

Who is sponsoring clinical trial NCT00733330?

This trial is sponsored by DePuy International, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00733330's enrollment target sits among peer trials

86 926th of 2000 higher than 1,073 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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

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Source: ClinicalTrials.gov NCT00733330, the US trial registry maintained by the National Library of Medicine. NCT00733330 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.