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Computer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: Comparing the Alignment Achieved Using the DePuy Ci Minimally Invasive (Mi) Versus the DePuy Non Navigated Conventional Total Knee Arthroplasty.

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What is being tested

Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique

+ Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation

Device
Who is being recruted

Apraxias+9

+ Arthritis

+ Joint Diseases

From 18 to 80 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2005
See protocol details

Summary

Principal SponsorDePuy International
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2005

Actual date on which the first participant was enrolled.

Primary endpoint: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA, specifically 3 months to demonstrate the variability of the mechanical axis. Secondary endpoints: to compare the precision of the long leg alignment of the Ci MiTKA vs. the non navigated conventional TKA specifically to demonstrate the proportion of procedures that fall within a satisfactory alignment window in either group.

Official TitleComputer Assisted Navigation in Minimally Invasive Total Knee Arthroplasty: Comparing the Alignment Achieved Using the DePuy Ci Minimally Invasive (Mi) Versus the DePuy Non Navigated Conventional Total Knee Arthroplasty.
NCT00733330
Principal SponsorDePuy International
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApraxiasArthritisJoint DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsOsteoarthritisPsychomotor DisordersRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

5 inclusion criteria required to participate
Male or female subjects aged between 18 and 80 years inclusive.
Subjects who require a primary total knee replacement and are considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
Subjects who are able to give and have given voluntary, written informed consent to participate in this clinical investigation.
Subjects who have given consent to the transfer of his/her information to DePuy.
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16 exclusion criteria prevent from participating
Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
Subjects who have a fixed flexion contracture of greater than 10º.
Subjects who are clinically obese i.e. BMI ≥30.
Subjects who have, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique

Group II

Active Comparator
Patients to receive treatment with either a P.F.C. or L.C.S. knees in chronological order into the CAS group which will use minimally invasive surgery and computer navigation

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Newport Orthopaedic Institute

Newport Beach, United StatesOpen Newport Orthopaedic Institute in Google Maps
Suspended

Wake Forest University

Winston-Salem, United States
Suspended

Joint Reconstruction Center, UPMC

Pittsburgh, United States
Suspended

Sportsmed

Adelaide, Australia
Suspended5 Study Centers