Osteoarthritis of the Knee
Conditions
Keywords
osteoarthritis, knee, treatment
Brief summary
A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.
Detailed description
The objective of this research is to evaluate the short-term results of viscosupplementation in patients with advanced osteoarthritis of the knee. There is a bigger demand of patients requiring total knee arthroplasty than the number of surgeries performed by the Unified Health System in Brazil. For this reason the queues to perform this surgery are huge and time-consuming in the referral hospitals. Whereas all these patients are suffering from severe pain and limiting, and awaiting the surgery for a few years, it is necessary to try any treatment, even if temporary, to ease the pain and suffering of those patients. A double-blind randomized prospective study will be held at Hospital Federal dos Servidores do Estado do Rio de Janeiro, with patients from the waiting list for Total Knee Arthroplasty who accept to participate and sign the informed consent form. Will be selected the last 150 knees in TKA queue. Patients will be randomized and divided in 3 groups of 50 knees. A group will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile Triamcinolone Hexacetonide solution 20 mg/ml). A second group will be subjected to administration of 6 ml of Hylan GF20. The third group will receive Hylan GF20 associated with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of Hylan GF20). The injection technique will be the same for all patients. The outcome results will be measured by a form with patient data, functional scores (Knee Society Score and Lysholm) before treatment and at one, three and six months after treatment.
Interventions
DRUGHylan G-F 20
intra-articular administration
DRUGTriamcinolone
Intra-articular administration
Sponsors
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old; * Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue); * Acceptance and signature of the TFCC;
Exclusion criteria
* Infiltration of the knee for the past 6 months; * Allergic to any substance used in the study; * Prior infection in the knee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm M1 | One month | The outcome will be measured by Lysholm Score within one month. The results will be compared within each group from baseline and between the 3 groups. |
| KSS M1 | One month | The outcome will be measured by Knee Society Score within one month. The results will be compared within each group from baseline and between the 3 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm M3 | Three months | The outcome will be measured by Lysholm Score within three months. The results will be compared within each group from baseline and between the 3 groups. |
| KSS M3 | Three months | The outcome will be measured by Knee Society Score within three months. The results will be compared within each group from baseline and between the 3 groups. |
| Lysholm M6 | Six months | The outcome will be measured by Lysholm Score within six months. The results will be compared within each group from baseline and between the 3 groups. |
| KSS M6 | Six months | The outcome will be measured by Knee Society Score within six months. The results will be compared within each group from baseline and between the 3 groups. |
Countries
Brazil
Contacts
Primary ContactAndre Campos
Backup ContactVinicius Gameiro
Outcome results
None listed