Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000505404
Ethics application status
Approved
Date submitted
27/08/2007
Date registered
4/10/2007
Date last updated
4/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study assessing Periarticular Knee Osteotomy Surgery Outcomes with or without Autologous Chrondrocyte Implantation (MACI technique).
Scientific title
A prospective Controlled Trial assessing Periarticular Knee Osteotomy Surgery Outcomes with or without Autologous Chrondrocyte Implantation (MACI technique).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 2299 0
Condition category
Condition code
Musculoskeletal 2396 2396 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High Tibial Osteotomy (HTO) is a well established operation for osteoarthritis. The principle of this surgery is as follows: in patients with arthritis localised to one side of their joint (usually the medial side) and a corresponding alignment that places the majority of their weight in this area, correcting the alignment to place the body weight towards the other side of the joint will usually relieve symptoms as well as slow the progression of the arthritis. The damaged articular cartilage is thought to then have some potential also to repair or regenerate. Another option is to combine this procedure with another well established technique of articular cartilage transplantation (MACI) to restore the joint surface in the arthritic side of the knee joint. The purpose of this study is to compare the clinical and Magnetic Resonance Imaging (MRI) results of patients who simply have an HTO alone, with those who have an HTO combined with MACI, to determine whether or not addition of this new technique enhances the regeneration and repair of damaged cartilage in knee joints with arthritis. This will have significant implications for our ability to treat arthritis and return arthritic joints back to normal function.
Intervention code [1] 2016 0
Treatment: Surgery
Comparator / control treatment
The historical group will be previous study patients who have had the high tibial osteotomy without MACI procedure (NSH Protocol No. 0501-004M)
Control group
Historical

Outcomes
Primary outcome [1] 3298 0
Articular Cartilage Glycosaminoglycan (GAG) content assessment (dGEMRIC MRI): This procedure includes the administration of gadolinium. This injection will be done by a qualified doctor in case of allergic reaction to the radiological contrast being administered. MRI is performed precontrast and at 1.5 hr after an intravenous injection of Gd-DTPA(2-) at 0.2 mmol/kg body weight. This procedure is regularly used in MRI diagnostic imaging and not different from normal routine radiological practice.
Timepoint [1] 3298 0
All patients to have MRI preoperatively. MRI involving volumetric analysis and dGEMRIC analysis will be performed at 1 year and 2 years postoperatively.
Primary outcome [2] 3314 0
Articular Cartilage morphology and volumetric assessment: For the tibial and femoral cartilage, MRI's are acquired in the frontal plane with a spoiled 3D gradient echo sequence with selective water excitation. An in-plane resolution of 0.312x0.312 mm and a slice thickness of 1.4 mm will be used. Post-processing: Previous validated post-processing software will be used to determine the mean thickness of medial and lateral tibia and femur.
Timepoint [2] 3314 0
All patients to have MRI preoperatively. MRI involving volumetric analysis and dGEMRIC analysis will be performed at 1 year and 2 years postoperatively.
Secondary outcome [1] 5666 0
Pain, stiffness, and physical functional disability: Disease specific problem will be evaluated with the Knee Injury and Osteoarthritis Outcome Score, and International Knee Documentation Committee (IKDC) subjective outcome scores.
Timepoint [1] 5666 0
6 and 12 months

Eligibility
Key inclusion criteria
Inclusion will involve those patients who have been placed on waiting list for high tibial osteotomy. The patients will be offered the opportunity to take part in the trial, with no consequences for early withdrawal.
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded, or removed from the study due to severe claustrophobia in MRI scanner, Gadolinium sensitivity or patients’ withdrawal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Historical controls that have a high tibial osteotomy without MACI procedure will be compared to patients that have a high tibial osteotomy with MACI.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2676 0
Self funded/Unfunded
Name [1] 2676 0
Sydney Orthopaedic Research Institute
Country [1] 2676 0
Australia
Primary sponsor type
Other
Name
Sydney Orthopaedic Research Institute
Address
Level 1, The Gallery,
445 Victoria Avenue,
Chatswood NSW 2067
Country
Australia
Secondary sponsor category [1] 2405 0
None
Name [1] 2405 0
Address [1] 2405 0
Country [1] 2405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4595 0
Northern Sydney Central Coast NSW Health
Ethics committee address [1] 4595 0
The Research Office
Level 4 Vindin House
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 4595 0
Australia
Date submitted for ethics approval [1] 4595 0
Approval date [1] 4595 0
19/09/2007
Ethics approval number [1] 4595 0
0609-170M

Summary
Brief summary
The study is a prospective investigation analyzing the outcomes of patients with unicompartmental osteoarthritis undergoing osteotomy (HTO). We will compare the outcomes of patients undergoing HTO alone, to those undergoing the combined procedure of HTO and MACI resurfacing of the arthritic femoral and tibial surfaces of the involved compartment. It has been shown previously that some articular surface regeneration can occur with HTO alone, although the amount and quality of this regenerate is not well defined. The next stage in evolution of regeneration would seem to be to directly promote this by chondrocyte transplantation.
Techniques such as MACI have successfully improved patient outcomes in the treatment of isolated chondral defects. The next step would be to show these improvements are possible in patients with more advanced osteoarthritis.
Before advocating this however, it is important to show objective advantages of this technique over HTO alone.
The outcomes will be assessed radiologically and clinically, and if the combined procedure is shown to have superior results, this would provide greater evidence for increased application of this technology. In addition, this would demonstrate a clear advantage of the MACI technique over periosteal patch techniques due to the difficulty of application of periosteal patches to diffuse arthritic defects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28007 0
Address 28007 0
Country 28007 0
Phone 28007 0
Fax 28007 0
Email 28007 0
Contact person for public queries
Name 11164 0
Karen Beatty
Address 11164 0
Level 1, The Gallery, 445 Victoria Avenue, Chatswood NSW 2067
Country 11164 0
Australia
Phone 11164 0
02 9904-7182
Fax 11164 0
Email 11164 0
[email protected]
Contact person for scientific queries
Name 2092 0
Karen Beatty
Address 2092 0
Level 1, The Gallery, 445 Victoria Avenue, Chatswood NSW 2067
Country 2092 0
Australia
Phone 2092 0
02 9904-7182
Fax 2092 0
Email 2092 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
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