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

NCT01079455 | Unknown Phase 3

• 1 other identifier: 2009-014274-17
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 1

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.

Conditions

Coxarthrosis

Keywords

Coxarthrosis; Hip; Infiltration; Hyaluronic Acid; Corticosterone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Visual Analog Score

  0 - 6 - 12 - 26 weeks

Study Arms (3)

HA

ACTIVE COMPARATOR

Coxarthrosis

Drug: Corticosterone

Corticosterone

ACTIVE COMPARATOR

Coxarthrosis

Drug: Corticosterone

Bupivacaine

PLACEBO COMPARATOR

Coxarthrosis

Drug: Corticosterone

Interventions

Corticosterone DRUG

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

Also known as: Hyaluronic Acid, Bupivacaine

Bupivacaine; Corticosterone; HA

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Pellenberg: lead

Study Sites (1)

University Hospital Pellenberg

Leuven, Belgium

Location

Related Publications (1)

• 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.

  PMID: 21080920 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Corticosterone; Hyaluronic Acid; Bupivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glycosaminoglycans; Polysaccharides; Carbohydrates; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sascha Colen, MD

  University Hospital Pellenberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha Colen, MD

CONTACT

0032497180798; sascolen@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 3, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2013
• Last Updated: March 3, 2010

Record last verified: 2010-02

Locations

BE (1)