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

Primary Purpose

Coxarthrosis

Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Corticosterone
Sponsored by
University Hospital Pellenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coxarthrosis focused on measuring Coxarthrosis, Hip, Infiltration, Hyaluronic Acid, Corticosterone

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Pellenberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

HA

Corticosterone

Bupivacaine

Arm Description

Coxarthrosis

Coxarthrosis

Coxarthrosis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2010
Last Updated
March 2, 2010
Sponsor
University Hospital Pellenberg
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1. Study Identification

Unique Protocol Identification Number
NCT01079455
Brief Title
Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Pellenberg

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coxarthrosis
Keywords
Coxarthrosis, Hip, Infiltration, Hyaluronic Acid, Corticosterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
489 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HA
Arm Type
Active Comparator
Arm Description
Coxarthrosis
Arm Title
Corticosterone
Arm Type
Active Comparator
Arm Description
Coxarthrosis
Arm Title
Bupivacaine
Arm Type
Placebo Comparator
Arm Description
Coxarthrosis
Intervention Type
Drug
Intervention Name(s)
Corticosterone
Other Intervention Name(s)
Hyaluronic Acid, Bupivacaine
Intervention Description
Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml
Primary Outcome Measure Information:
Title
Harris Hip Score
Description
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.
Time Frame
0 - 6 - 12 - 26 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Score
Description
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
Time Frame
0 - 6 - 12 - 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sascha Colen, MD
Phone
0032497180798
Email
sascolen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sascha Colen, MD
Organizational Affiliation
University Hospital Pellenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Pellenberg
City
Leuven
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sascha Colen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21080920
Citation
Colen S, van den Bekerom MP, Bellemans J, Mulier M. Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors. BMC Musculoskelet Disord. 2010 Nov 16;11:264. doi: 10.1186/1471-2474-11-264.
Results Reference
derived

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

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