Prophecy Guide Outcomes in Total Knee Replacement Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2010 by Global Orthopaedic Technology
Sponsor:
Collaborator:
LSS Surgical Pty Ltd
Information provided by:
Global Orthopaedic Technology
ClinicalTrials.gov Identifier:
NCT01163708
First received: July 14, 2010
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

This project aims to assess two different techniques used to position the knee replacement implant during surgery. The patients will be randomised to receive either the following:

  1. The established Navigation System (gold standard)
  2. The new Prophecy Technique (validated by the Navigation System)

The study hypothesis is there will be no difference between the gold standard Navigation system and the Prophecy technique in relation to the placement of the knee implant.


Condition Intervention Phase
Osteoarthritis of the Knee
Total Knee Replacement
Device: Prophecy Technique
Device: Navigation System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Phase IV Study - Prophecy Guide Outcomes in Total Knee Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Global Orthopaedic Technology:

Primary Outcome Measures:
  • Prophecy Guide Outcomes in Total Knee Replacement Surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to investigate the Prophecy technique and compare its outcomes to the established navigation (Gold standard) technique


Secondary Outcome Measures:
  • Prophecy Guide Outcomes in Total Knee Replacement Surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    The secondary objectives are to evaluate the:

    1. Post-Operative Knee Alignment
    2. Implant sizing
    3. Implant position
    4. Tourniquet time
    5. Anaesthesia time
    6. Duration of surgery
    7. Validation of Prophecy MRI protocol
    8. Validation of bone resection


Estimated Enrollment: 188
Study Start Date: August 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Navigation alone
Navigation system alone vs Prophecy technique with Navigation system validation
Device: Navigation System
Experimental: Prophecy and Navigation validation Device: Prophecy Technique
Navigation computerised system is used intraoperatively to correct implant the Advance knee implant. Prophecy is a pre-alignment technique where a pre-op MRI or CT scan is used to manufacture personalised cutting blocks to assist the surgeon in correct implanting the Advance knee implant intraoperatively
Other Name: Prophecy Preoperative alignment

Detailed Description:

Knee joint pain is often the cause of reduced joint and limb function. Total knee joint replacement is a procedure which aims to relieve pain and help to improve mobility. There has been continued development and improvement in knee implant design and the instruments required during surgery to assist with the accurate placement of the implant. These developments have reduced surgery time and assisted in the accurate positioning of the knee implant, which leads to better long term outcomes.

Navigation system is a computerised system currently used intraoperatively to position the Advance knee implant. The Prophecy technique is a pre-operative alignment technique. Patient undergo a MRI or CT scan which is used to manufacture personalised cutting blocks which are then used intraoperatively to position the knee implant.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients requiring a total Knee Arthroplasty as determined jointly by the surgeon and the patient.
  2. Over 65 years of age at time of surgery.
  3. Patients with the Varus or Valgus Osteoarthritis
  4. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
  5. Patients who are capable of, and have given, informed consent to their participation in the study.
  6. The individual does not have an active infection within the affected joint.
  7. The individual has not had a previous total knee replacement or knee fusion of the affected knee joint.
  8. The individual is skeletally mature.
  9. The individual is not pregnant.
  10. The individual is not a prisoner.
  11. The individual has no plans to relocate to another geographic area before the completion of the study.

Exclusion Criteria:

  1. Previous surgery requiring implanting a device.
  2. Knee deformity is >30° anatomic varus (as measured on an AP radiograph taken with the patient standing)
  3. Knee deformity is >30° anatomic valgus (as measured on an AP radiograph taken with the patient standing) >20° knee flexion contracture (as measured by investigator examination)
  4. Those patients requiring bone grafting or any other procedure that would extend the operative time beyond that of just replacing the knee should be excluded.
  5. The individual is classified as morbidly obese (>40 BMI).
  6. The individual is physically or mentally compromised (i.e., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse), and is unwilling or unable to comply with postoperative scheduled clinical and radiographic evaluation and rehabilitation.
  7. The individual has a neuromuscular or neuro-sensory deficiency which limits the ability to evaluate the safety and effectiveness of the device.
  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: NCT01163708

Contacts
Contact: Hugh English +61 1300 436 454 hugh@boss.net.au
Contact: Kath Hore +61 1300 436 454 kath@boss.net.au

Locations
Australia, Queensland
Holy Spirit Northside Private Hospital Not yet recruiting
Chermside, Queensland, Australia, 4032
Contact: Kath Hore    + 61 1300 436 454    kath@boss.net.au   
Contact: Gladys Williams    +61 2 8887 0116    gladys.williams@globalortho.com.au   
Principal Investigator: Hugh English         
Sub-Investigator: Anthony Ganko         
Prince Charles Hospital Not yet recruiting
Chermside, Queensland, Australia, 4032
Contact: Kath Hore    1300 436 454    kath@boss.net.au   
Contact: Gladys Williams    +61 2 8887 0116    gladys.williams@globalortho.com.au   
Principal Investigator: Hugh English         
Sub-Investigator: Anthony Ganko         
Sponsors and Collaborators
Global Orthopaedic Technology
LSS Surgical Pty Ltd
Investigators
Principal Investigator: Hugh English Brisbane Orthopaedic Specialist Services
  More Information

No publications provided

Responsible Party: Dr Hugh English - Principal Investigator, Brisbane Orthopaedic Specialist Services
ClinicalTrials.gov Identifier: NCT01163708     History of Changes
Other Study ID Numbers: Pro-Nav-10
Study First Received: July 14, 2010
Last Updated: July 27, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on October 22, 2014