Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000756224
Ethics application status
Approved
Date submitted
28/08/2009
Date registered
1/09/2009
Date last updated
2/08/2024
Date data sharing statement initially provided
2/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Patient Outcome Following Autologous Chondrocyte Implantation: Accelerated versus Conservative Rehabilitation
Scientific title
Improving Clinical and Radiological Outcomes Following Autologous Chondrocyte Implantation: Accelerated versus Conservative Rehabilitation
Secondary ID [1] 312672 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Articular Cartilage Defects in the Knee 243603 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239889 239889 0 0
Other physical medicine / rehabilitation
Musculoskeletal 239894 239894 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will provide two differing approaches to post-operative rehabilitation following autologous chondrocyte implantation (ACI), a technique to address articular cartilage defects in the knee.

All patients are enrolled in the rehabilitation program for 12 weeks, and will attend rehabilitation for two sessions per week (1-2 hours duration). These sessions will be fully supervised (one-to-one supervision) by an Accredited Exercise Physiotherapist. Whilst progressive resistance, range of motion and hydrotherapy exercises will be the same for both rehabilitation groups, the gradient and time to full weight bearing (WB) following surgery will differ.

The traditionally ‘conservative’ protocol (Group 1) consists of a five week period of WB at 20% (toe-touch) body weight (BW), followed by a progressive increase to full WB at 11 weeks post-surgery. The ‘accelerated’ protocol progressively increases WB immediately with full WB attained at eight weeks post-surgery.
Intervention code [1] 241190 0
Rehabilitation
Comparator / control treatment
This study will compare an accelerated rehabilitation regime, with the traditionally 'conservative' regime.

All patients are enrolled in the rehabilitation program for 12 weeks, and will attend rehabilitation for two sessions per week (1-2 hours duration). These sessions will be fully supervised (one-to-one supervision) by an Accredited Exercise Physiotherapist. Whilst progressive resistance, range of motion and hydrotherapy exercises will be the same for both rehabilitation groups, the gradient and time to full weight bearing (WB) following surgery will differ.

The traditionally ‘conservative’ protocol (Group 1) consists of a five week period of WB at 20% (toe-touch) body weight (BW), followed by a progressive increase to full WB at 11 weeks post-surgery. The ‘accelerated’ protocol progressively increases WB immediately with full WB attained at eight weeks post-surgery.
Control group
Active

Outcomes
Primary outcome [1] 240674 0
'Magnetic Resonance Imaging (MRI)' will be used, in conjunction with specific MRI sequencing to assess articular cartilage regeneration.

As per the articular cartilage repair scoring methods developed by Marlovits et al. (2004 - Definition of pertinent parameters for the evaluation of articular cartilage
repair tissue with high-resolution magnetic resonance imaging), we shall assess pertinet parameters of tissue repair. These include graft infill, border integration, surface contour, structure and signal intensity of repair tissue, status of subcondral lamina and bone, adhesions and joint effusion.
Timepoint [1] 240674 0
Post-surgery at 3, 12, 24 and 60-months.
Primary outcome [2] 240675 0
Active knee flexion and extension are measured with the patient in a supine position.
Timepoint [2] 240675 0
Pre-surgery, and post-surgery at 3, 6, 12, 24, 36, 48 and 60-months.
Primary outcome [3] 240680 0
The three-repetition maximum straight leg raise (3RM-SLR) test is administered to assess the strength of the quadriceps and hip flexor musculature in a supine position.
Timepoint [3] 240680 0
Pre-surgery, and post-surgery at 3, 6, 12, 24, 36, 48 and 60-months.
Primary outcome [4] 240682 0
The six minute walk test measures the maximum distance the patient can walk in a six minute time period, whereby patients are instructed to walk as far and fast as they comfortably can for the duration of the test.
Timepoint [4] 240682 0
Pre-surgery, and post-surgery at 3, 6, 12, 24, 36, 48 and 60-months.
Primary outcome [5] 240683 0
Activity level is assessed using accelerometers (Actigraph, MTI Health Services, Ft. Walton Beach, FL) for seven days, which provides the total number of steps per day.
Timepoint [5] 240683 0
Post-surgery at 3, 6 and 12-months.
Primary outcome [6] 240684 0
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will assess knee pain, symptoms, activities of daily living (ADL), sport and recreation and knee related quality of life (QOL).
Timepoint [6] 240684 0
Pre-surgery, and post-surgery at 3, 6, 12, 24, 36, 48 and 60-months.
Primary outcome [7] 240685 0
The Short Form Health Survey (SF-36) evaluates the general health of the patient, producing a mental (MCS) and physical component score (PCS).
Timepoint [7] 240685 0
Pre-surgery, and post-surgery at 3, 6, 12, 24, 36, 48 and 60-months.
Primary outcome [8] 240686 0
A Visual Analogue Scale (VAS) assesses the frequency (VAS-F) and severity (VAS-S) of knee pain on a scale of 0-10.
Timepoint [8] 240686 0
Pre-surgery, and post-surgery at 3, 6, 12, 24, 36, 48 and 60-months.
Secondary outcome [1] 257313 0
'Biomechanical Gait Assessment' is assessed using three-dimensional (3D) gait analysis, conducted at the Gait Laboratory in the School of Sport Science, Exercise and Health, at the University of Western Australia (UWA) using a seven-camera VICON motion analysis system (VICON MX, Oxford Metrics Limited, Oxford, UK) operating at 50 Hz. Data from two AMTI force plates (Advanced Mechanics Technology Incorporated, Watertown, USA) will also record at 2000 Hz, synchronously with the motion data. Measurement of segmental movement is facilitated with retro-reflective markers attached to the pelvis, thigh, shank, foot and trunk of the subject using double-sided adhesive tape.

A number of variables will be investigated to describe gait function in the two patient groups. Knee kinematic variables associated with the stance phase of the gait cycle included knee angle at heel strike (HS), weight acceptance (WA) and mid stance (MS), as well as the change in knee angle from HS to WA (KROM). Ground reaction forces (GRF) of interest included peak vertical GRF (peak GRFV), as well as GRFV during weight acceptance (GRFV1), the trough during mid stance (GRFV2) and the peak in push off (GRFV3), normalized to patient BW (%BW). The peak knee adduction moment is recorded, as well as the two traditional peak values during weight acceptance (M1ADD) and push-off (M3ADD) and the trough around mid stance (M2ADD). The peak knee flexion moment is also measured, as are the two peaks typically observed during the stance phase of the gait cycle (M1FLEX and M2FLEX) and the peak knee extension moment (M1EXT). Spatio-temporal variables are calculated for each trial, namely gait speed, cadence, stride length and width.
Timepoint [1] 257313 0
Post-surgery at 3, 6 and 12 months

Eligibility
Key inclusion criteria
Male or female subjects; Aged between 16-65 years; Localised, full thickness medial or lateral femoral condylar defects (<10cm2 upon MRI evaluation); Trochlear or patella defects, provided they are in conjunction with a primary condylar defect; Chondral or osteochondral lesions; Ligamentous deficiencies, provided they are addressed prior to or at the time of surgery; Acceptance of rehabilitation procedure by subject; Having provided written informed consent.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple defects; Isolated trochlear or patella defects; Presence of ongoing, progressive inflammatory arthritis; Unstable knee joint; Obesity exceeding >35 using the body mass index (BMI); Varus or valgus abnormalities (>+2°; <-5° (tibiofemoral anatomical angle)); Known allergy towards gentamycin or hypersensitivity; Known allergy towards products of bovine or porcine origin; Osteonecrosis; Chondrocalcinosis; Osteoarthritis; Rheumatoid arthritis; Infectious diseases; and Pregnancy.

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)
Once patients have been assessed by the surgeon for the associated inclusion/ exclusion criteria, are well informed about the study and provide their written, informed consent, randomisation will be undertaken.

Allocation is concealed, and involves contacting the holder of the allocation schedule who is locate at an independent office “off-site”.

A block randomisation procedure (gender; age – less than/greater than 35 years) is used to allocate patients to either the experimental (accelerated rehabilitation) or control (traditional rehabilitation) groups before baseline evaluation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A ‘random number generator’ using Microsoft Excel will create a random list numbers (1=accelerated; 2=traditional).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
18/12/2007
Date of last data collection
Anticipated
Actual
20/01/2013
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 237546 0
Hospital
Name [1] 237546 0
Hollywood Private Hospital
Country [1] 237546 0
Australia
Funding source category [2] 237547 0
Government body
Name [2] 237547 0
The National Health and Medical Research Council (NHMRC)
Country [2] 237547 0
Australia
Funding source category [3] 237548 0
University
Name [3] 237548 0
University of Western Australia
Country [3] 237548 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Stirling Highway, Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 237026 0
None
Name [1] 237026 0
Address [1] 237026 0
Country [1] 237026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243683 0
Hollywood Private Hospital Ethics Committee
Ethics committee address [1] 243683 0
Ethics committee country [1] 243683 0
Australia
Date submitted for ethics approval [1] 243683 0
01/03/2003
Approval date [1] 243683 0
01/06/2003
Ethics approval number [1] 243683 0
HPH145

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30096 0
Dr Jay Ebert
Address 30096 0
University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
Country 30096 0
Australia
Phone 30096 0
+61 421922402
Fax 30096 0
Email 30096 0
[email protected]
Contact person for public queries
Name 13343 0
Dr Jay Ebert
Address 13343 0
University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
Country 13343 0
Australia
Phone 13343 0
+61 421922402
Fax 13343 0
+61 8 9346 6462
Email 13343 0
[email protected]
Contact person for scientific queries
Name 4271 0
Dr Jay Ebert
Address 4271 0
University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
Country 4271 0
Australia
Phone 4271 0
+61 421922402
Fax 4271 0
+61 8 9346 6462
Email 4271 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be provided to preserve participant anonymity, only pooled group data is available.


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.