Outcomes of Injections in Patients Waiting for Total Knee Replacement
Primary Purpose
Osteoarthritis of the Knee
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Hylan G-F 20
Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis, knee, treatment
Eligibility Criteria
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.
Sites / Locations
- Hospital dos Servidores do Estado do Rio de JaneiroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Hylan
Hylan + Corticosteroid
Corticosteroid
Arm Description
Intra-articular (knee) 6ml Hylan GF20 administration (single shot)
Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)
Intra-articular (knee) 1ml Triamcinolone administration (single shot)
Outcomes
Primary Outcome Measures
Lysholm M1
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
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 Outcome Measures
Lysholm M3
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
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
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
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.
Full Information
NCT ID
NCT03090698
First Posted
March 2, 2017
Last Updated
March 20, 2017
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT03090698
Brief Title
Outcomes of Injections in Patients Waiting for Total Knee Replacement
Official Title
Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis, knee, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hylan
Arm Type
Active Comparator
Arm Description
Intra-articular (knee) 6ml Hylan GF20 administration (single shot)
Arm Title
Hylan + Corticosteroid
Arm Type
Active Comparator
Arm Description
Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Intra-articular (knee) 1ml Triamcinolone administration (single shot)
Intervention Type
Drug
Intervention Name(s)
Hylan G-F 20
Intervention Description
intra-articular administration
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
Intra-articular administration
Primary Outcome Measure Information:
Title
Lysholm M1
Description
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.
Time Frame
One month
Title
KSS M1
Description
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.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Lysholm M3
Description
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.
Time Frame
Three months
Title
KSS M3
Description
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.
Time Frame
Three months
Title
Lysholm M6
Description
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.
Time Frame
Six months
Title
KSS M6
Description
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.
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andre Campos
Phone
+55 21 22913131
Ext
3374
Email
andresiqueiracampos@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vinicius Gameiro
Email
drschott@bol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Campos
Organizational Affiliation
Hospital dos Servidores do Estado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital dos Servidores do Estado do Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
20.221-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Campos
Phone
+55 21 22913131
Ext
3374
Email
andresiqueiracampos@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Outcomes of Injections in Patients Waiting for Total Knee Replacement
We'll reach out to this number within 24 hrs