Prophecy Guide Outcomes in Total Knee Replacement Surgery
NCT ID: NCT01163708
Last Updated: 2010-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
188 participants
INTERVENTIONAL
2010-08-31
2017-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Navigation alone
Navigation system alone vs Prophecy technique with Navigation system validation
Navigation System
Prophecy and Navigation validation
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
Interventions
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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
Navigation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
65 Years
85 Years
ALL
No
Sponsors
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LSS Surgical Pty Ltd
UNKNOWN
Global Orthopaedic Technology
INDUSTRY
Responsible Party
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Brisbane Orthopaedic Specialist Services
Principal Investigators
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Hugh English
Role: PRINCIPAL_INVESTIGATOR
Brisbane Orthopaedic Specialist Services
Locations
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Holy Spirit Northside Private Hospital
Chermside, Queensland, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Countries
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Central Contacts
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Facility Contacts
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Kath Hore
Role: primary
Gladys Williams
Role: backup
Kath Hore
Role: primary
Gladys Williams
Role: backup
Other Identifiers
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Pro-Nav-10
Identifier Type: -
Identifier Source: org_study_id