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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01163708




Registration number
NCT01163708
Ethics application status
Date submitted
14/07/2010
Date registered
16/07/2010
Date last updated
29/07/2010

Titles & IDs
Public title
Prophecy Guide Outcomes in Total Knee Replacement Surgery
Scientific title
Phase IV Study - Prophecy Guide Outcomes in Total Knee Replacement Surgery
Secondary ID [1] 0 0
Pro-Nav-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 0 0
Total Knee Replacement 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Prophecy Technique

Active comparator: Navigation alone - Navigation system alone vs Prophecy technique with Navigation system validation

Experimental: Prophecy and Navigation validation -


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prophecy Guide Outcomes in Total Knee Replacement Surgery
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Prophecy Guide Outcomes in Total Knee Replacement Surgery
Timepoint [1] 0 0
5 years

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2017
Actual
Sample size
Target
188
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Holy Spirit Northside Private Hospital - Chermside
Recruitment hospital [2] 0 0
Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
4032 - Chermside

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Global Orthopaedic Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
LSS Surgical Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01163708
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hugh English
Address 0 0
Brisbane Orthopaedic Specialist Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hugh English
Address 0 0
Country 0 0
Phone 0 0
+61 1300 436 454
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01163708