Prophecy Guide Outcomes in Total Knee Replacement Surgery

NCT01163708 | Unknown Phase 4

• 1 other identifier: Pro-Nav-10
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 2

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

Conditions

Osteoarthritis of the Knee; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Prophecy Guide Outcomes in Total Knee Replacement Surgery

  The primary objective of this study is to investigate the Prophecy technique and compare its outcomes to the established navigation (Gold standard) technique

  5 years

Secondary Outcomes (1)

• Prophecy Guide Outcomes in Total Knee Replacement Surgery

  5 years

Study Arms (2)

Navigation alone

ACTIVE COMPARATOR

Navigation system alone vs Prophecy technique with Navigation system validation

Device: Navigation System

Prophecy and Navigation validation

EXPERIMENTAL

Device: Prophecy Technique

Interventions

Prophecy Technique DEVICE

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

Also known as: Prophecy Preoperative alignment

Prophecy and Navigation validation

Navigation System DEVICE

Navigation alone

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Global Orthopaedic Technology: lead
• LSS Surgical Pty Ltd: collaborator

Study Sites (2)

Holy Spirit Northside Private Hospital

Chermside, Queensland, 4032, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Surgical Navigation Systems

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Hugh English

  Brisbane Orthopaedic Specialist Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugh English

CONTACT

+61 1300 436 454; hugh@boss.net.au

Kath Hore

CONTACT

+61 1300 436 454; kath@boss.net.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 29, 2010

Record last verified: 2010-07

Locations

AU (2)