Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip

Study Overview
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Brief Summary
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Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee. Methods: Randomized controlled trial with three-armed parallel-group design. The patients meeting the inclusion criteria will be randomized into one of the following groups: infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine 0,125%. Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked to determine their situation as worse, stabile or better then at the time of enrollment. There will be asked if they use painkillers and if they have complications/adverse events. These outcome measure instruments will be used at the time of enrollment in the study prior to any injection, and then again at six weeks, 3 and 6 months after the initial injection. The six-month follow-up period begins for all patients on the date the first injection will be administered.

Official Title
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Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip Controlled With Intra-articular Injections With Bupivacaine

Conditions
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Coxarthrosis

Intervention / Treatment
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* Drug: Corticosterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: an age between 30 and 70years radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3) chronic pain for at least 3 months prior to study entry (day 0) dissatisfaction with prior attempts at non-operative management including nonsteroidal anti-inflammatory drugs. Exclusion Criteria: Kellgren and Lawrence grade 4 an intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months non compliance to the study procedures and or non completion of the study according to investigator's judgment rapid destructive hip. a history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy a current other problem in the affected extremity contra-indications for the use of corticosteroids (gastrointestinal ulcer, severe osteoporosis, psychiatric anamnesis, herpes simplex or zoster (viremic stadium), varicella, 8 weeks before and 2 weeks after immunization, systemic mycosis, poliomyelitic except of bulbar encephalitic form lymphadenitis after BCG-vaccination, parenteral depot medication, closed- and wide-angle glaucoma) allergy or hypersensitivity to any of the study medications or to contrast solutions.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HA<br>Coxarthrosis | Drug: Corticosterone<br>* Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml<br>* Other names: Bupivacaine;|
| Active Comparator: Corticosterone<br>Coxarthrosis | Drug: Corticosterone<br>* Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml<br>* Other names: Bupivacaine;|
| Placebo Comparator: Bupivacaine<br>Coxarthrosis | Drug: Corticosterone<br>* Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml<br>* Other names: Bupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | this score will be used as a self-administered questionnaire in accordance with the developers' instructions. The Harris Hip Score was first developed in 1967 and is accepted as one of the best used questionnaires dealing the hip function. It is a disease-specific scoring system which was introduced to provide an evaluation system for various hip disabilities and methods of treatment. This Score gives a maximum of 100 points, with domains of pain, function, deformity and motion. | 0 - 6 - 12 - 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score | this score is a self-assessment of variation in pain intensity, measured on a simple 100-mm-long continuous scale of absolutes ranging from no pain to extreme pain. The percentage of pain is determined by physical measuring from the end of the line to the patients' mark on the pain scale, and divided by total length of the line. The advantage of the VAS is that you can determine the change in pain by taking the difference between any two recordings of pain severity | 0 - 6 - 12 - 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Coxarthrosis, Infiltration, Hyaluronic Acid, Corticosterone