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

NCT ID: NCT00733330

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2010-12-31

Brief 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.

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional TKR arm

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

Group Type: OTHER

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

Intervention Type: DEVICE

Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation

MiTKR CAS arm

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation

Interventions

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

Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation

Intervention Type: DEVICE

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

Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation

Intervention Type: DEVICE

Eligibility 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 1.
• Subjects who have inflammatory arthritis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Newport Orthopaedic Institute

Newport Beach, California, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Joint Reconstruction Center, UPMC

Pittsburgh, Pennsylvania, United States

Sportsmed

Adelaide, South Australia, Australia

Ascot & Mercy Hospital

Remuera, Aukland 5, New Zealand

Countries

United States; Australia; New Zealand

Other Identifiers

CT 03/10

Identifier Type: -

Identifier Source: org_study_id