Status:
UNKNOWN
Prophecy Guide Outcomes in Total Knee Replacement Surgery
Lead Sponsor:
Global Orthopaedic Technology
Collaborating Sponsors:
LSS Surgical Pty Ltd
Conditions:
Osteoarthritis of the Knee
Total Knee Replacement
Eligibility:
All Genders
65-85 years
Phase:
PHASE4
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 ...
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 dev...
Eligibility Criteria
Inclusion
- Patients requiring a total Knee Arthroplasty as determined jointly by the surgeon and the patient.
- Over 65 years of age at time of surgery.
- Patients with the Varus or Valgus Osteoarthritis
- Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
- Patients who are capable of, and have given, informed consent to their participation in the study.
- The individual does not have an active infection within the affected joint.
- The individual has not had a previous total knee replacement or knee fusion of the affected knee joint.
- The individual is skeletally mature.
- The individual is not pregnant.
- The individual is not a prisoner.
- The individual has no plans to relocate to another geographic area before the completion of the study.
Exclusion
- Previous surgery requiring implanting a device.
- Knee deformity is \>30° anatomic varus (as measured on an AP radiograph taken with the patient standing)
- 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)
- 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.
- The individual is classified as morbidly obese (\>40 BMI).
- 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.
- The individual has a neuromuscular or neuro-sensory deficiency which limits the ability to evaluate the safety and effectiveness of the device.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT01163708
Start Date
August 1 2010
End Date
December 1 2017
Last Update
July 29 2010
Active Locations (2)
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1
Holy Spirit Northside Private Hospital
Chermside, Queensland, Australia, 4032
2
Prince Charles Hospital
Chermside, Queensland, Australia, 4032