Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000872831
Ethics application status
Not yet submitted
Date submitted
15/08/2012
Date registered
17/08/2012
Date last updated
17/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of low-pressure knee arthroscopy on patients with osteoarthritis and the levels of pain, bone marrow oedema and degree of function 6-weeks post procedure.
Scientific title
Efficacy of low-pressure knee arthroscopy on pain, bone marrow oedema and function in patients with osteoarthritis, 6-weeks post procedure: A prospective single-blinded randomised control trial
Secondary ID [1] 281032 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with mild-moderate osteoarthritis of the knee who are referred for surgical therapy, which in this case is arthroscopy, due to the failure of medical and physical therapy to adequately manage their condition. 287168 0
Condition category
Condition code
Musculoskeletal 287494 287494 0 0
Osteoarthritis
Surgery 287515 287515 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will undergo arthroscopy as per the usual standard of this procedure. What will vary will be the pressure of the fluid used to visualise the joint with the arthroscopic device. In this case the fluid pressure will be run at 30mmHg as opposed to the standard pressure which can vary amongst different health centres but in this case will be 80mmHg. The length of the procedure can vary from patient-to-patient depending on what is discovered during the procedure by the surgeon. It is a day surgery procedure with the length of this lower pressure arthroscopy taking the same length of time as standard pressure.
Intervention code [1] 285493 0
Treatment: Surgery
Comparator / control treatment
This group will receive arthroscopy under standard pressure. In this case, patients will undergo arthroscopy as per the normal standard of care with a higher fluid pressure, e.g. 80mmHg, rather than 30mmHg.
Control group
Active

Outcomes
Primary outcome [1] 287749 0
Knee pain measured on the visual analogue scale
Timepoint [1] 287749 0
Prior to and 6-weeks post procedure
Primary outcome [2] 287750 0
Bone marrow oedema measured by magnetic resonance imaging of the knee
Timepoint [2] 287750 0
Prior to and 6-weeks post procedure
Secondary outcome [1] 298770 0
Degree of function of the affected knee measured by the Knee injury and Osteoarthritis Outcome Score
Timepoint [1] 298770 0
Prior to and 6-weeks post procedure

Eligibility
Key inclusion criteria
1. Patients with osteoarthritis who have been diagnosed via medical imaging and in whom a total knee replacement is not indicated.
2. Indication for arthroscopy is either for meniscal or cartilage debridement.
3. Patient can weight bear as tolerated post procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to consent.
2. Bone marrow oedema pre-procedure.
3. Requirement of additional intra-operative procedures to be performed (e.g. deemed necessary by the operating surgeon due to unanticipated circumstances)
4. Inadequate visualisation of the knee joint intra-operatively requiring the operating surgeon to adjust the joint fluid pressure from what has been allocated for this patient.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285819 0
University
Name [1] 285819 0
James Cook University
Country [1] 285819 0
Australia
Primary sponsor type
Individual
Name
Stewart Hunt
Address
James Cook University School of Medicine, Mackay Base Hospital, Bridge Road, Mackay, Queensland, 4740
Country
Australia
Secondary sponsor category [1] 284645 0
None
Name [1] 284645 0
Address [1] 284645 0
Country [1] 284645 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287834 0
The Townsville Health Service District Institutional Ethics Committee
Ethics committee address [1] 287834 0
PO Box 670, Townsville, QLD, 4810
Ethics committee country [1] 287834 0
Australia
Date submitted for ethics approval [1] 287834 0
23/08/2012
Approval date [1] 287834 0
Ethics approval number [1] 287834 0

Summary
Brief summary
This trial will be looking at patients who have osteoarthritis of the knee. Such patients will be referred by their doctor for knee arthroscopy. These patients usually have mild-moderate osteoarthritis of the knee and will undergo arthroscopy to reduce their pain and improve function. At the moment, when the arthroscopy is performed, a certain fluid pressure is used. This trial will try using a lower pressure and compare it with the current standard. It is hypothesised that patients who get the lower pressure will have less pain, less bone marrow swelling and increased degree of function. These are the three areas the trial will be assessing and will be comparing this with patients who get the current standard pressure, 6 weeks after the arthroscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34580 0
Address 34580 0
Country 34580 0
Phone 34580 0
Fax 34580 0
Email 34580 0
Contact person for public queries
Name 17827 0
Stewart Hunt
Address 17827 0
JCU School of Medicine, Mackay Base Hospital, Bridge Road, Mackay, Queensland, 4740
Country 17827 0
Australia
Phone 17827 0
+61748857102
Fax 17827 0
Email 17827 0
[email protected]
Contact person for scientific queries
Name 8755 0
Stewart Hunt
Address 8755 0
JCU School of Medicine, Mackay Base Hospital, Bridge Road, Mackay, Queensland, 4740
Country 8755 0
Australia
Phone 8755 0
+61438351190
Fax 8755 0
Email 8755 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.