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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital Pellenberg.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital Pellenberg
ClinicalTrials.gov Identifier:
NCT01079455
First received: March 1, 2010
Last updated: March 2, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Coxarthrosis
Drug: Corticosterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital Pellenberg:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 0 - 6 - 12 - 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 - 6 - 12 - 26 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 489
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079455

Contacts
Contact: Sascha Colen, MD 0032497180798 sascolen@hotmail.com

Locations
Belgium
University Hospital Pellenberg Not yet recruiting
Leuven, Belgium
Principal Investigator: Sascha Colen, MD         
Sponsors and Collaborators
University Hospital Pellenberg
Investigators
Principal Investigator: Sascha Colen, MD University Hospital Pellenberg
  More Information

No publications provided by University Hospital Pellenberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Pellenberg
ClinicalTrials.gov Identifier: NCT01079455     History of Changes
Other Study ID Numbers: 2009-014274-17
Study First Received: March 1, 2010
Last Updated: March 2, 2010
Health Authority: Belgium: University Hospital Pellenberg

Keywords provided by University Hospital Pellenberg:
Coxarthrosis
Hip
Infiltration
Hyaluronic Acid
Corticosterone

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Corticosterone
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014