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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA | Active Comparator | Coxarthrosis |
|
| Corticosterone | Active Comparator | Coxarthrosis |
|
| Bupivacaine | Placebo Comparator | Coxarthrosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosterone | Drug | Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sascha Colen, MD | Contact | 0032497180798 | sascolen@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sascha Colen, MD | University Hospital Pellenberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Pellenberg | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21080920 | Derived | 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. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003345 | Corticosterone |
| D006820 | Hyaluronic Acid |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| 0 - 6 - 12 - 26 weeks |
| D012216 |
| Rheumatic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |