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Prophecy Guide Outcomes in Total Knee Replacement Surgery

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ClinicalTrials.gov Identifier: NCT01163708
Recruitment Status : Unknown
Verified July 2010 by Global Orthopaedic Technology.
Recruitment status was:  Not yet recruiting
First Posted : July 16, 2010
Last Update Posted : July 29, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Osteoarthritis of the Knee Total Knee Replacement Device: Prophecy Technique Device: Navigation System Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Phase IV Study - Prophecy Guide Outcomes in Total Knee Replacement Surgery
Study Start Date : August 2010
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Prophecy Guide Outcomes in Total Knee Replacement Surgery [ Time Frame: 5 years ]
    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 :
  1. Prophecy Guide Outcomes in Total Knee Replacement Surgery [ Time Frame: 5 years ]

    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010

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