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

Coxarthrosis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01079455
• Other study ID #: 2009-014274-17
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 1, 2010
• Last updated: March 2, 2010
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2010
• Source: University Hospital Pellenberg
• Contact: Sascha Colen, MD
• Phone: 0032497180798
• Email: sascolen[@]hotmail.com
• Is FDA regulated: No
• Health authority: Belgium: University Hospital Pellenberg
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 489
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• Corticosterone
Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml

Locations

Country	Name	City	State
Belgium	University Hospital Pellenberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Pellenberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 - 6 - 12 - 26 weeks	No
Secondary	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	0 - 6 - 12 - 26 weeks	No