Project Arthritis Recovering Quality of Life Through Education - Hip

July 25, 2019 updated by: Marcia Uchoa Rezende, University of Sao Paulo General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month, 6 months and 12 months
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)
1 month, 6 months and 12 months
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)
1 month, 6 months and 12 months
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)
1 month, 6 months and 12 months
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
1 month, 6 months and 12 months
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
1 month, 6 months and 12 months
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
1 month, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Guilherme Ocampos, MD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

December 20, 2019

Study Completion (Anticipated)

December 20, 2020

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04019418700000068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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