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Project Arthritis Recovering Quality of Life Through Education - Hip

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ClinicalTrials.gov Identifier: NCT04018690
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Marcia Uchoa Rezende, University of Sao Paulo General Hospital

Brief Summary:

Introduction: One in four people are at risk of developing symptomatic hip OAH. Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered 20th century surgery, with high cost-effectiveness in patients who are not responding to clinical treatment.

Joint lavage with saline shows significant pain relief in patients with knee and hip OA. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscosupplementation.

In the investigators experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of the majority of patients with OAH grades 2 and 3 of K & L undergoing the procedure. Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. In previous studies by the investigators, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year.

Objective: To evaluate whether lavage followed by injection of triamcinolone, ropivacaine and 4 mL of hylan in the affected joint (Hilano) improves function, range of motion, pain, quality of life and muscle strength in patients with OAH in the early stages METHODS: 48 patients from the public network attended by the Orthopedics and Traumatology Institute of the General Hospital of the Medical School of the University of São Paulo, already identified with bilateral OA of the hip submitted to THR in one limb and the other limb presenting OA mild or moderate with indication of non-surgical treatment will be submitted to lavage, saline infiltration and CS (control group) or lavage, saline infiltration, CS and Hilano. Patients will be assessed at 1, 3, 6 and 12 months after the procedure using standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain, range of motion and strength using an isokinetic dynamometer.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine, Not Applicable

Detailed Description:

Hip OA (OAH) is less frequent than that of the hand and knee OA. One in four people have the risk of developing symptomatic OA of the hip.

Most guidelines for OAQ treatment combine recommendations for the treatment of knee and hip OA although OAH has specific etiopathogenic characteristics with its implications for individual therapeutic approaches.

Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered to be 20th-century surgery with high cost-effectiveness in patients who are not responding to the clinical treatment of OA.

Measures that decrease inflammation and release capsular retraction leading to symptoms of pain and restriction of joint amplitude may improve the quality of life of these patients in the earliest stages of the disease.

Joint lavage with saline shows significant relief of pain in patients with knee and hip OA, probably by intra-articular removal of debris and factors that cause irritation and inflammation. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscossuplementation.

In our experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of most patients with OAH grades 2 and 3 of Kellgren and Lawrence undergoing the procedure.

The viscossuplementation of the hip has not yet been established in regard to type, dose, indication or frequency, and the number of existing jobs is relatively small in relation to those performed on knee osteoarthritis (OAK). Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. Its prolonged effect is explained by the action of hyaluronic acid on the CD44 receptors of synoviocytes and by the reduction of activated serum T cell levels. In our experience, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year.

Thus, the investigators developed a study to improve the range of motion and the function of patients with mild to moderate OA of the hip through lavage with physiological saline and hydraulic distension comparing to lavage, hydraulic distension and CS injection, anesthetic and a dose of 4mL of G-F20 hilano.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Project Arthritis Recovering Quality of Life Through Education - Hip
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: Experimental
24 patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.
Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine

Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.

Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.

Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.

Costs will be evaluated for cost-effectiveness and cost-utility analysis.


Active Comparator: Control Group
24 patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine
Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,

Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.

Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.

Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.

Costs will be evaluated for cost-effectiveness and cost-utility analysis.





Primary Outcome Measures :
  1. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and ropivacaine improves range of flexion in the 3rd postoperative month in respect to lavage e triamcinolone injection. [ Time Frame: 3 months ]
    Evaluate amplitudes of movement of hip flexion, extension, abduction and adduction; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.


Secondary Outcome Measures :
  1. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Range of flexion, Range of motion (extension, adduction and abduction), Strength of flexion, extension, adduction e abduction. [ Time Frame: 1 month, 6 months and 12 months ]
    Evaluate amplitudes of movement of hip flexion, extension, abduction and adduction; the hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees / second.

  2. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Womac questionnaire (Range minimum 0 - range maximum 96)

  3. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Lequesne [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Lequesne questionnaire (Range minimum 0 - range maximum 24)

  4. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: VAS [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer Visual Analogue Scale (Range minimum 0 - range maximum 100)

  5. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: EuroQol Questionnaire [ Time Frame: 1 month, 6 months and 12 months ]
    All patients will answer EuroQol questionnaire

  6. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine increases Lean Mass Percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate lean mass of all patients

  7. Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine decrease fat percentage [ Time Frame: 1 month, 6 months and 12 months ]
    Calculate fat percentage of all patients



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women diagnosed with bilateral OAH with or without comorbidities (metabolic syndrome, i.e. OA + at least two of overweight / central obesity, diabetes, dyslipidemia, hypertension)
  • Age between 60 and 75 years who are awaiting primary THR, with indication of non-surgical treatment in the contralateral limb
  • Patients without previous arthroplasties in the lower limbs.
  • Patients with no personal history of chronic inflammatory arthritis (rheumatoid arthritis, for example).
  • Patients with no personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, comprehension, in order to impair the assimilation of the given guidelines.
  • Patients able to read, understand and respond to questionnaires and perform functional tests.

Exclusion Criteria:

  • Fail to intervene and not perform the tasks determined by the professionals.
  • Patients diagnosed during the study with chronic inflammatory arthritis (rheumatoid arthritis, for example)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018690


Contacts
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Contact: Livia Abreu 1126612473 murmedicina@outlook.com

Locations
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Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Guilherme Ocampos, MD University of São Paulo General Hospital

Publications:
Balaz EA. Chemistry and biology of hyaluronan. In: Garg HG, Hales CA, editors. Chemistry and biology of hyaluronan. Elsevier; 2004. p. 415-55

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Responsible Party: Marcia Uchoa Rezende, Full Professor in Orthopedics and Traumatology, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04018690     History of Changes
Other Study ID Numbers: 04019418700000068
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcia Uchoa Rezende, University of Sao Paulo General Hospital:
Hip Osteoarthritis
Quality of Life
Function
Viscosuplementação

Additional relevant MeSH terms:
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Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Ropivacaine
Hylan
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Viscosupplements
Protective Agents