Project Arthritis Recovering Quality of Life Through Education - Hip

NCT04018690 | Unknown

• 1 other identifier: 04019418700000068
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

Hip Osteoarthritis; Quality of Life; Function; Viscosuplementação

Outcome Measures

Primary Outcomes (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.

  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.

  3 months

Secondary Outcomes (7)

• 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.

  1 month, 6 months and 12 months

• Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac

  1 month, 6 months and 12 months

• Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Lequesne

  1 month, 6 months and 12 months

• Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: VAS

  1 month, 6 months and 12 months

• Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: EuroQol Questionnaire

  1 month, 6 months and 12 months

Study Arms (2)

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

Control Group

ACTIVE COMPARATOR

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,

Interventions

Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine BEHAVIORAL

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.

Experimental

Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine, BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-010, Brazil

Location

Related Publications (37)

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MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

hylan; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Guilherme Ocampos, MD

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia Abreu

CONTACT

1126612473; murmedicina@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 12, 2019
• Study Start: September 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2020
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)