Minimally Invasive Total Knee Replacement - Navigated Versus Non-Navigated Study - Full Text View

Sponsored by:	DePuy International
Information provided by:	DePuy International
ClinicalTrials.gov Identifier:	NCT00733330

Purpose

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, ie 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.

Condition	Intervention	Phase
Osteoarthritis	Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement Device: Either P.F.C. Sigma or L.C.S. Complete knee	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:

To compare the precision of the long leg alignment of the Ci MiTKA versus the non-navigated conventional TKA - specifically, 3 months post-operatively. [ Time Frame: 6 - 12 weeks, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the accuracy of a Ci MiTKA versus a non-navigated, conventional TKA. Specifically, to demonstrate the proportion of procedures that fall within a satisfactory alignment window is greater using a navigated procedure versus non navigated. [ Time Frame: 12 weeks, 6 months, 1, 2 and 5 years post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	154
Study Start Date:	January 2005
Study Completion Date:	November 2008

Arms	Assigned Interventions
Conventional TKR arm: Experimental 77 patients to receive treatment with either a P.F.C. Sigma or L.C.S. knee using the conventional manual surgical technique	Device: Either P.F.C. Sigma or L.C.S. Complete knee replacement Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation
MiTKR CAS arm: Experimental 77 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	Device: Either P.F.C. Sigma or L.C.S. Complete knee Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

Exclusion Criteria:

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.
Female subjects who are pregnant or lactating.
Subjects who are known drug or alcohol abusers or have a psychological disorder that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical investigation with an investigational product in the last 3 months.
Subjects currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
Subjects who have previously had a prosthetic knee replacement device (any type) of the affected knee.
Subjects who present with ankylosis of the hip joint on the side to be treated or previous ipsilateral Upper Tibial Osteotomy/High Tibial Osteotomy.
Subjects who require simultaneous bilateral total knee replacements.
Subjects who have had a contralateral TKA performed less than six months before the proposed TKA.
Subjects who have had a contralateral TKA and that knee was previously entered in the study.
Subjects who, in the opinion of the surgeon, will require a contralateral TKA within 6 months of the index procedure.
Subjects in whom the surgeon intends to implant a knee component that is not one of those listed in Table
Subjects who have inflammatory arthritis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733330

Locations

United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
Australia, South Australia
Sportsmed
Adelaide, South Australia, Australia, 5069

Sponsors and Collaborators

DePuy International

Investigators

Principal Investigator:

David Pollock, FRCS

Wake Forest University, Carolina

More Information

No publications provided

Responsible Party:	DePuy International (See above) ( Mick Borroff )
Study ID Numbers:	CT 03/10
Study First Received:	August 11, 2008
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00733330 History of Changes
Health Authority:	Australia: Human Research Ethics Committee; United States: Institutional Review Board

Keywords provided by DePuy International:

Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 26, 2009