Plain English Summary
Background and study aims
In the normal joint, healthy cartilage allows bones to glide easily over each other .It also helps absorb shock of movement by its cushion like effect. Osteoarthritis is the most common joint disease that mostly affects cartilage particularly of major joints (such as the knee) due to chronic stresses on the joints from, for example, certain jobs and playing sports, obesity, genetic defects in joint cartilage or due to injury. It is common in the elderly due to wear and tear on the joint and rubbing of joint surfaces; this leads to destruction of cartilage and eventually narrowing of joint space, swelling, loss of joint movement, stiffness and significant pain. Pain is the most common symptom of osteoarthritis. It usually occurs when the joint is moved and improves at rest. It gradually becomes more severe due to the progression of disease and development of inflammation (swelling). The pain and stiffness affects the function of the joints and impacts upon a person’s everyday life. Treatment focuses on pain relief and improving the physical function of the joint. In the most severe cases surgical replacement of the osteoarthritic joint can be performed, but this is major surgery and carries surgical risks and complications. The aim of this study is to look at whether an injection of fat from another area of the body into a knee with severe osteoarthritis improves their condition.
Who can participate?
Adults with moderate to severe knee osteoarthritis
What does the study involve?
Patients are first told what the treatment involves and are asked to give consent. The treatment involves using the self-lubricating effect of their own fat (autologous fat) inside the joint to improve joint function and reduce the pain and stiffness they experience. The surgical site for fat donation is selected according to patients’ wishes and fat availability. The surgery is performed as day care surgery under local anaesthesia and sedation. During the surgery, the fat is obtained and prepared, then injected inside the joint cavity of the osteoarthritic knee. Patients are discharged soon afterwards with antibiotics and pain killers. All patients are then followed up to see if joint function has improved and whether there is a reduction in pain and stiffness of the joint.
What are the possible benefits and risks of participating?
Possible benefits include improvement in a patients quality of life and a reduction in the chance of severe joint damage and a reduced likelihood of needing joint replacement in the future.
Where is the study run from?
King Abdulaziz University Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
August 2010 to December 2016
Who is funding the study?
King Abdulaziz University Hospital
Who is the main contact?
Professor Sabah Moshref
dr.sabahmoshref@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Sabah Moshref
ORCID ID
http://orcid.org/0000-0002-7407-4390
Contact details
King Abdulaziz University Hospital
P.O Box 80215
Jeddah
21589
Saudi Arabia
+966505617886
dr.sabahmoshref@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
No. 822-12
Study information
Scientific title
Intra-articular Injection of autologous fat graft for the treatment of knee osteoarthritis
Acronym
Study hypothesis
Does a simple injection of autologous fat graft improve chronic osteoarthritis
Ethics approval
Local Research and Ethics Committee, 15/05/2012, ref 822-12
Study design
Interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available’
Condition
Osteoarthritis
Intervention
Patients are told what the treatment involves and are asked to give consent. The treatment involves using the self-lubricating effect of their own fat (autologous fat) inside the joint to improve joint function and reduce pain and stiffness. The surgical site for liposuction is then selected according to patients’ wishes and fat availability. The surgery is performed as day care surgery under local anaesthesia and sedation under complete aseptic technique. During the surgery, the fat is obtained and prepared, then injected inside the joint cavity of the osteoarthritic knee via small microcannula. The patient is discharged with antibiotics and pain killers.
Post procedure all patients are followed up in the outpatient clinic on regular basis twice in the first month and then every three months to check for any side effects, complications, assessment of pain, stiffness and knee functions.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measures
Improvement in the pain and stiffness of the joint physical function by the combined lubricating and regenerative effect of fluid preparation. This is measured by pain experienced at rest and during activity using the visual analogue score (VAS) at preoperative visit and postoperative visit.
Secondary outcome measures
1. Joint physical function, measured using the Western Ontario and McMaster Universities Osteoarthritis Index at 3 months after surgery
2. Extent of repair of the osteoarthritic joint as indicated by arthroscopy of the fat injected joint (a minimally invasive surgical procedure to examine the damage of the joint) at 3 months after surgery
Overall trial start date
29/08/2010
Overall trial end date
29/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Adults with severe to moderate knee osteoarthritis changes, confirmed by bilateral anterior - posterior standing and lateral supine radiographs involving one or both knees
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Recent knee surgery
2. Chronic opoid intake
3. Bleeding disorders
4. Malignant disease
5. A congenital or traumatic deformity of the knee joint
6. Refusal of the patient to be included
Recruitment start date
20/12/2011
Recruitment end date
20/10/2015
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Abdulaziz University Hospital
P.O Box 80215
Jeddah
21589
Saudi Arabia
Sponsor information
Organisation
King Abdulaziz University Hospital
Sponsor details
King Abdulaziz University
Jeddah
21589
Saudi Arabia
+966126401000
ysjamal@kau.edu.sa
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
King Abdulaziz University Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are planning to publish "Intra-articular Injection of Autologous Fat Graft for the Treatment of Knee Osteoarthritis" in a BMC journal.
Intention to publish date
31/12/2016
Participant level data
Available on request
Results - basic reporting
See additional file (ISRCTN49625613_BasicResults_11Jan18"
Publication summary
Publication citations
Additional files
- ISRCTN49625613_BasicResults_11Jan18.pdf Uploaded 14/02/2018