Intra-articular injection of fat micro graft: simple treatment for knee osteoarthritis with local injection of patient own fat
| ISRCTN | ISRCTN49625613 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49625613 |
| Secondary identifying numbers | No. 822-12 |
- Submission date
- 26/04/2016
- Registration date
- 11/05/2016
- Last edited
- 14/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
King Abdulaziz University Hospital
P.O Box 80215
Jeddah
21589
Saudi Arabia
 ORCID ID |
0000-0002-7407-4390 |
|---|---|
| Phone | +966505617886 |
| dr.sabahmoshref@gmail.com |
Study information
| Study design | Interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available’ |
| Scientific title | Intra-articular Injection of autologous fat graft for the treatment of knee osteoarthritis |
| Study objectives | Does a simple injection of autologous fat graft improve chronic osteoarthritis |
| Ethics approval(s) | Local Research and Ethics Committee, 15/05/2012, ref 822-12 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 29/08/2010 |
| Completion date | 29/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/12/2011 |
| Date of final enrolment | 20/10/2015 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Jeddah
21589
Saudi Arabia
Sponsor information
University/education
King Abdulaziz University
Jeddah
21589
Saudi Arabia
| Phone | +966126401000 |
|---|---|
| ysjamal@kau.edu.sa | |
"ROR" |
https://ror.org/02ma4wv74 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 11/01/2018 | 14/02/2018 | No | No |
Additional files
- ISRCTN49625613_BasicResults_11Jan18.pdf
- Uploaded 14/02/2018
Editorial Notes
14/02/2018: The basic results of this trial have been uploaded as an additional file.
