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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-12-31

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.

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Detailed Description

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Conditions

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Coxarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HA

Coxarthrosis

Group Type ACTIVE_COMPARATOR

Corticosterone

Intervention Type DRUG

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

Corticosterone

Coxarthrosis

Group Type ACTIVE_COMPARATOR

Corticosterone

Intervention Type DRUG

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

Bupivacaine

Coxarthrosis

Group Type PLACEBO_COMPARATOR

Corticosterone

Intervention Type DRUG

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

Interventions

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Corticosterone

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

Intervention Type DRUG

Other Intervention Names

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Hyaluronic Acid Bupivacaine

Eligibility Criteria

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Inclusion Criteria

1. an age between 30 and 70years
2. radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3)
3. chronic pain for at least 3 months prior to study entry (day 0)
4. dissatisfaction with prior attempts at non-operative management including nonsteroidal anti-inflammatory drugs.

Exclusion Criteria

1. Kellgren and Lawrence grade 4
2. an intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months
3. non compliance to the study procedures and or non completion of the study according to investigator's judgment
4. rapid destructive hip.
5. a history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy
6. a current other problem in the affected extremity
7. 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)
8. allergy or hypersensitivity to any of the study medications or to contrast solutions.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No