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Prophecy Guide Outcomes in Total Knee Replacement Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
LSS Surgical Pty Ltd
Information provided by:
Global Orthopaedic Technology

Tracking Information
First Submitted Date  ICMJE July 14, 2010
First Posted Date  ICMJE July 16, 2010
Last Update Posted Date July 29, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prophecy Guide Outcomes in Total Knee Replacement Surgery
Official Title  ICMJE Phase IV Study - Prophecy Guide Outcomes in Total Knee Replacement Surgery
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE
  • Osteoarthritis of the Knee
  • Total Knee Replacement
Intervention  ICMJE
  • 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
  • Device: Navigation System
Study Arms  ICMJE
  • Active Comparator: Navigation alone
    Navigation system alone vs Prophecy technique with Navigation system validation
    Intervention: Device: Navigation System
  • Experimental: Prophecy and Navigation validation
    Intervention: Device: Prophecy Technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)
188
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163708
Other Study ID Numbers  ICMJE Pro-Nav-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Hugh English - Principal Investigator, Brisbane Orthopaedic Specialist Services
Study Sponsor  ICMJE Global Orthopaedic Technology
Collaborators  ICMJE LSS Surgical Pty Ltd
Investigators  ICMJE
Principal Investigator: Hugh English Brisbane Orthopaedic Specialist Services
PRS Account Global Orthopaedic Technology
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP