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

Sponsor

University Hospital Pellenberg (Other)

Overall Status

Unknown status

CT.gov ID

NCT01079455

Collaborator

(none)

489

Enrollment

Location

Arms

Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coxarthrosis	Drug: Corticosterone	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

489 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HA Coxarthrosis	Drug: Corticosterone Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml Other Names: Hyaluronic Acid Bupivacaine
Active Comparator: Corticosterone Coxarthrosis	Drug: Corticosterone Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml Other Names: Hyaluronic Acid Bupivacaine
Placebo Comparator: Bupivacaine Coxarthrosis	Drug: Corticosterone Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml Other Names: Hyaluronic Acid Bupivacaine

Arm

Intervention/Treatment

Active Comparator: HA

Coxarthrosis

Drug: Corticosterone

Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml

Other Names:

Hyaluronic Acid

Bupivacaine

Active Comparator: Corticosterone

Coxarthrosis

Drug: Corticosterone

Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml

Other Names:

Hyaluronic Acid

Bupivacaine

Placebo Comparator: Bupivacaine

Coxarthrosis

Drug: Corticosterone

Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml

Other Names:

Hyaluronic Acid

Bupivacaine

Outcome Measures

Primary Outcome Measures

Harris Hip Score [0 - 6 - 12 - 26 weeks]
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.

Secondary Outcome Measures

Visual Analog Score [0 - 6 - 12 - 26 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.