Osteoarthritis Clinical Trial
Official title:
Treatment of Osteoarthritis With the Stromal Vascular Fraction of Abdominal Adipose Tissue - a Pilot Study
Verified date | August 2017 |
Source | Hvidovre University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the feasibility and short term safety issues of treatment of knee
osteoarthritis with intra-articular injection with the stromal vascular fraction of abdominal
adipose tissue (SVF) harvested and prepared using the Lipogems System.
Hereby we wish to pave the road for a high quality randomized controlled trial investigating
effectiveness of treatment of knee osteoarthritis with SVF looking at patient reported
outcome, function, homeostasis of the joint and cartilage regeneration.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: Age 18-70 years. Kellgren-Lawrence grade 1 - 4 evaluated on x-ray or ICRS grade 2-4 evaluated on MRI. The patient must be expected to be able to attend rehabilitation and post-examinations. The patient must be able to speak and understand Danish. The patient must be able to give informed consent. Exclusion Criteria: Varus or valgus malalignment of the knee > 5 degrees. BMI > 35 Terminal illness or severe medical illness: ASA score higher than or equal to 3. |
Country | Name | City | State |
---|---|---|---|
Denmark | Copenhagen University Hospital Koege | Koege |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | An adverse event is defined as any event caused by the treatment leading to a less preferable situation for the patient. Patients will be screened for: Donor site morbidity: (Infection, swelling, pain). Implant site morbidity: (Infection, swelling, pain (increased VAS score)) |
3 months | |
Secondary | The Knee injury and Osteoarthritis Outcome Score | The KOOS holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL) | 3+12 months | |
Secondary | Numeric Rating Scale for Assessment of Pain Intensity | For assessment of pain intensity, the 11-step numeric rating scale (NRS-11) is chosen. The scale goes from 0 to10, with 0 equalling no pain and 10 being the worst possible pain | 3+12 months |
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