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

This study has been terminated.
(A sample size recalculation indicated an increase from 154 to 1500 subjects was required so the study stopped as new target was considered unfeasible.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733330
First received: August 11, 2008
Last updated: July 23, 2013
Last verified: July 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • To compare the precision of the long leg alignment between the 2 treatment groups. [ Time Frame: 6 - 12 Weeks ] [ Designated as safety issue: No ]
    Alignment will be measured on long leg weight bearing X-rays performed when the subject has full leg extension (+/-5 degrees)


Secondary Outcome Measures:
  • To compare the proportion of procedures that fall within a satisfactory alignment window between the 2 treatment groups. [ Time Frame: operative ] [ Designated as safety issue: No ]
    An independent radiographic observer will determine and record alignment.

  • To compare the number of optimal implantations achieved by the 2 groups from pre-op to 6-12 weeks. [ Time Frame: 4 - 12 Weeks ] [ Designated as safety issue: No ]
    Achieved alignment results will be measured on post-op X-rays taken at the time the subject has achieved full extension.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: Pre-op ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare American Knee Society Score between 2 treatment groups. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subject's affected knee and it details the clinical condition and functionality of the joint.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: pre-op ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare Oxford Knee Scores between 2 treatment groups. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their daily activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: pre-op ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare the WOMAC scores between the 2 treatment groups [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    WOMAC evaluates the subject's perception of their condition, functionality of affected joint and the impact it has on normal everyday activities.

  • To compare VAS pain scores between the 2 treatment groups. [ Time Frame: pre-op ] [ Designated as safety issue: No ]
    The VAS pain score measures the subjects perception of their pain at any moment in time.

  • To compare VAS pain scores between the 2 treatment groups. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    The VAS pain score measures the subjects perception of their pain at any moment in time.

  • To compare VAS pain scores between the 2 treatment groups. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    The VAS pain score measures the subjects perception of their pain at any moment in time.

  • To compare VAS pain scores between the 2 treatment groups. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The VAS pain score measures the subjects perception of their pain at any moment in time.

  • To compare VAS pain scores between the 2 treatment groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The VAS pain score measures the subjects perception of their pain at any moment in time.

  • To compare interface radiographic appearance between the 2 treatment groups [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    An independent radiographer will observe and record alignment.

  • To compare the change from 6-12 Weeks & 5 years on long leg alignment. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    an independent radiographer will observe and record alignment

  • To compare the 6 minute walk test scores between the 2 groups [ Time Frame: pre-op ] [ Designated as safety issue: No ]
    This score records the total distance walked in 6 minutes (this time includes any time that the subject needs to stop and rest). Pre-operatively, the subject must complete both a practice walk and a test walk.

  • To compare the 6 minute walk test scores between the 2 groups [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This score records the total distance walked in 6 minutes (this time includes any time that the subject needs to stop and rest).

  • To compare the 6 minute walk test scores between the 2 groups [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    This score records the total distance walked in 6 minutes (this time includes any time that the subject needs to stop and rest).

  • To compare the 6 minute walk test scores between the 2 groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This score records the total distance walked in 6 minutes (this time includes any time that the subject needs to stop and rest).

  • To compare the 6 minute walk test scores between the 2 groups [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This score records the total distance walked in 6 minutes (this time includes any time that the subject needs to stop and rest).


Enrollment: 86
Study Start Date: January 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional TKR arm
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
Experimental: MiTKR CAS arm
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 1.
  • Subjects who have inflammatory arthritis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
New Zealand
Ascot & Mercy Hospital
Remuera, Aukland 5, New Zealand
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: David Pollock, FRCS Wake Forest University, Carolina
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733330     History of Changes
Other Study ID Numbers: CT 03/10
Study First Received: August 11, 2008
Last Updated: July 23, 2013
Health Authority: Australia: Human Research Ethics Committee
United States: Institutional Review Board

Keywords provided by DePuy International:
Arthroplasty, Knee, TKA, TKR, CAS, minimally invasive

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 09, 2014