Osteoarthritis of the KneePhase 4NCT01163708
Prophecy Guide Outcomes in Total Knee Replacement Surgery
A Phase 4 study testing Prophecy Technique and Navigation System in people with Osteoarthritis of the Knee and Total Knee Replacement, run by Global Orthopaedic Technology at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee, Total Knee Replacement
- What is being tested?
- Prophecy Technique and Navigation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2010to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Holy Spirit Northside Private Hospital
Chermside, Queensland, 4032
Kath Hore, + 61 1300 436 454, kath@boss.net.au
Gladys Williams, +61 2 8887 0116, gladys.williams@globalortho.com.au
Prince Charles Hospital
Chermside, Queensland, 4032
Kath Hore, 1300 436 454, kath@boss.net.au
Gladys Williams, +61 2 8887 0116, gladys.williams@globalortho.com.au
About this study
Official title: Phase IV Study - Prophecy Guide Outcomes in Total Knee Replacement Surgery
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:
- The established Navigation System (gold standard)
- 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.
Read the 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.
- Conditions
- Osteoarthritis of the Knee, Total Knee Replacement
- Being tested
- Prophecy Technique, Navigation System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophecy TechniqueDevice
Also called Prophecy Preoperative alignment
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 SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Navigation alone | Active comparator | Navigation system alone vs Prophecy technique with Navigation system validation Receives: Device: Navigation System |
| Prophecy and Navigation validation | Experimental | Not described Receives: Device: Prophecy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Prophecy Guide Outcomes in Total Knee Replacement Surgery
The secondary objectives are to evaluate the:
- Post-Operative Knee Alignment
- Implant sizing
- Implant position
- Tourniquet time
- Anaesthesia time
- Duration of surgery
- Validation of Prophecy MRI protocol
- Validation of bone resection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Orthopaedic Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LSS Surgical Pty Ltd
- Investigators
- Hugh English, Principal investigator, Brisbane Orthopaedic Specialist Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163708
- Sponsor's protocol ID
- Pro-Nav-10
- Status last verified
- Jul 2010
- First submitted
- 14 Jul 2010
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study - Prophecy Guide Outcomes in Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT01163708
- Acronym / sponsor ID
- Pro-Nav-10
- Conditions
- Osteoarthritis of the Knee, Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Global Orthopaedic TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- LSS Surgical Pty Ltd
- Study start
- Aug 2010
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The established Navigation System (gold standard)
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigation alone | Active comparator | Device: Navigation SystemNavigation system alone vs Prophecy technique with Navigation system validation |
| Prophecy and Navigation validation | Experimental | Device: Prophecy Technique |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophecy TechniqueAlso: Prophecy Preoperative alignmentNavigation 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 | Device | Prophecy and Navigation validation |
| Navigation System | Device | Navigation alone |
Primary outcome
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
1 secondary outcome
Prophecy Guide Outcomes in Total Knee Replacement Surgery
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh English principal investigator
Brisbane Orthopaedic Specialist Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prophecy Technique and Navigation System in people with Osteoarthritis of the Knee and Total Knee Replacement, run by Global Orthopaedic Technology at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugh English (+61 1300 436 454, hugh@boss.net.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prophecy Guide Outcomes in Total Knee Replacement Surgery (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2010.