Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: 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
Intervention description: Orthopaedic implants for total knee replacement implanted with a standard approach using standard instrumentation; Orthopaedic implants for total knee replacement implanted with a minimally invasive approach and computer navigation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive

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.
    

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.