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

March 2, 2010 updated by: University Hospital Pellenberg

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
489

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Leuven, Belgium
        • University Hospital Pellenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: HA
Coxarthrosis
Drug: Corticosterone
Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml
Other Names:
  • Bupivacaine
  • Hyaluronic Acid
ACTIVE_COMPARATOR: Corticosterone
Coxarthrosis
Drug: Corticosterone
Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml
Other Names:
  • Bupivacaine
  • Hyaluronic Acid
PLACEBO_COMPARATOR: Bupivacaine
Coxarthrosis
Drug: Corticosterone
Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml
Other Names:
  • Bupivacaine
  • Hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: 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.
0 - 6 - 12 - 26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Score
Time Frame: 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
0 - 6 - 12 - 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Pellenberg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sascha Colen, MD, University Hospital Pellenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009-014274-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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