Hip OsteoarthritisNCT04018690
Project Arthritis Recovering Quality of Life Through Education - Hip
A study testing Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine and Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine, in people with Hip Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine and Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-010
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine, Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,
- Keywords
- Hip Osteoarthritis, Quality of Life, Function, Viscosuplementação
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaineBehavioural
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.
Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 month, 6 months and 12 months
Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac
All patients will answer Womac questionnaire (Range minimum 0 - range maximum 96)
Measured: 1 month, 6 months and 12 months
Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Lequesne
All patients will answer Lequesne questionnaire (Range minimum 0 - range maximum 24)
Measured: 1 month, 6 months and 12 months
Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: VAS
All patients will answer Visual Analogue Scale (Range minimum 0 - range maximum 100)
Measured: 1 month, 6 months and 12 months
Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: EuroQol Questionnaire
All patients will answer EuroQol questionnaire
Measured: 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
Calculate lean mass of all patients
Measured: 1 month, 6 months and 12 months
Evaluate whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine decrease fat percentage
Calculate fat percentage of all patients
Measured: 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Uchoa Rezende, University of Sao Paulo General Hospital
- Investigators
- Guilherme Ocampos, MD, Principal investigator, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018690
- Sponsor's protocol ID
- 04019418700000068
- Status last verified
- Jul 2019
- First submitted
- 27 Jun 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.
PubMed 21907813Murphy LB, Helmick CG, Schwartz TA, Renner JB, Tudor G, Koch GG, Dragomir AD, Kalsbeek WD, Luta G, Jordan JM. One in four people may develop symptomatic hip osteoarthritis in his or her lifetime. Osteoarthritis Cartilage. 2010 Nov;18(11):1372-9. doi: 10.1016/j.joca.2010.08.005. Epub 2010 Aug 14.
PubMed 20713163Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
PubMed 18279766Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
PubMed 20170770Rillo O, Riera H, Acosta C, Liendo V, Bolanos J, Monterola L, Nieto E, Arape R, Franco LM, Vera M, Papasidero S, Espinosa R, Esquivel JA, Souto R, Rossi C, Molina JF, Salas J, Ballesteros F, Radrigan F, Guibert M, Reyes G, Chico A, Camacho W, Urioste L, Garcia A, Iraheta I, Gutierrez CE, Aragon R, Duarte M, Gonzalez M, Castaneda O, Angulo J, Coimbra I, Munoz-Louis R, Saenz R, Vallejo C, Briceno J, Acuna RP, De Leon A, Reginato AM, Moller I, Caballero CV, Quintero M. PANLAR Consensus Recommendations for the Management in Osteoarthritis of Hand, Hip, and Knee. J Clin Rheumatol. 2016 Oct;22(7):345-54. doi: 10.1097/RHU.0000000000000449.
PubMed 27660931Murphy NJ, Eyles JP, Hunter DJ. Hip Osteoarthritis: Etiopathogenesis and Implications for Management. Adv Ther. 2016 Nov;33(11):1921-1946. doi: 10.1007/s12325-016-0409-3. Epub 2016 Sep 26.
PubMed 27671326Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
PubMed 17964352Daigle ME, Weinstein AM, Katz JN, Losina E. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol. 2012 Oct;26(5):649-58. doi: 10.1016/j.berh.2012.07.013.
PubMed 23218429Chong T, Don DW, Kao MC, Wong D, Mitra R. The value of physical examination in the diagnosis of hip osteoarthritis. J Back Musculoskelet Rehabil. 2013;26(4):397-400. doi: 10.3233/BMR-130398.
PubMed 23948824de Sa D, Phillips M, Catapano M, Simunovic N, Belzile EL, Karlsson J, Ayeni OR. Adhesive capsulitis of the hip: a review addressing diagnosis, treatment and outcomes. J Hip Preserv Surg. 2015 Nov 27;3(1):43-55. doi: 10.1093/jhps/hnv075. eCollection 2016 Apr.
PubMed 27026818Ike RW, Arnold WJ, Rothschild EW, Shaw HL. Tidal irrigation versus conservative medical management in patients with osteoarthritis of the knee: a prospective randomized study. Tidal Irrigation Cooperating Group. J Rheumatol. 1992 May;19(5):772-9.
PubMed 1613709Chang RW, Falconer J, Stulberg SD, Arnold WJ, Manheim LM, Dyer AR. A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee. Arthritis Rheum. 1993 Mar;36(3):289-96. doi: 10.1002/art.1780360302.
PubMed 8452573Edelson R, Burks RT, Bloebaum RD. Short-term effects of knee washout for osteoarthritis. Am J Sports Med. 1995 May-Jun;23(3):345-9. doi: 10.1177/036354659502300317.
PubMed 7661265Vad VB, Sakalkale D, Warren RF. The role of capsular distention in adhesive capsulitis. Arch Phys Med Rehabil. 2003 Sep;84(9):1290-2. doi: 10.1016/s0003-9993(03)00261-2.
PubMed 13680563Vad VB, Sakalkale D, Sculco TP, Wickiewicz TL. Role of hylan G-F 20 in treatment of osteoarthritis of the hip joint. Arch Phys Med Rehabil. 2003 Aug;84(8):1224-6. doi: 10.1016/s0003-9993(03)00140-0.
PubMed 12917864
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Arthritis Recovering Quality of Life Through Education - Hip
- ClinicalTrials.gov ID
- NCT04018690
- Acronym / sponsor ID
- 04019418700000068
- Conditions
- Hip Osteoarthritis
- Keywords
- Hip Osteoarthritis, Quality of Life, Function, Viscosuplementação
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine24 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. |
| Control Group | Active comparator | Behavioral: Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,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 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacainePatients 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. | Behavioural | Experimental |
| 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. | Behavioural | Control Group |
Primary outcome
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.
7 secondary outcomes
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 whether needle lavage, followed by the injection of hylan, triamcinolone and 1 ropivacaine improves: Womac
Time frame: 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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 21907813Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.
- Background: PubMed 20713163Murphy LB, Helmick CG, Schwartz TA, Renner JB, Tudor G, Koch GG, Dragomir AD, Kalsbeek WD, Luta G, Jordan JM. One in four people may develop symptomatic hip osteoarthritis in his or her lifetime. Osteoarthritis Cartilage. 2010 Nov;18(11):1372-9. doi: 10.1016/j.joca.2010.08.005. Epub 2010 Aug 14.
- Background: PubMed 18279766Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.
- Background: PubMed 20170770Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11.
- Background: PubMed 27660931Rillo O, Riera H, Acosta C, Liendo V, Bolanos J, Monterola L, Nieto E, Arape R, Franco LM, Vera M, Papasidero S, Espinosa R, Esquivel JA, Souto R, Rossi C, Molina JF, Salas J, Ballesteros F, Radrigan F, Guibert M, Reyes G, Chico A, Camacho W, Urioste L, Garcia A, Iraheta I, Gutierrez CE, Aragon R, Duarte M, Gonzalez M, Castaneda O, Angulo J, Coimbra I, Munoz-Louis R, Saenz R, Vallejo C, Briceno J, Acuna RP, De Leon A, Reginato AM, Moller I, Caballero CV, Quintero M. PANLAR Consensus Recommendations for the Management in Osteoarthritis of Hand, Hip, and Knee. J Clin Rheumatol. 2016 Oct;22(7):345-54. doi: 10.1097/RHU.0000000000000449.
- Background: PubMed 27671326Murphy NJ, Eyles JP, Hunter DJ. Hip Osteoarthritis: Etiopathogenesis and Implications for Management. Adv Ther. 2016 Nov;33(11):1921-1946. doi: 10.1007/s12325-016-0409-3. Epub 2016 Sep 26.
- Background: PubMed 17964352Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
- Background: PubMed 23218429Daigle ME, Weinstein AM, Katz JN, Losina E. The cost-effectiveness of total joint arthroplasty: a systematic review of published literature. Best Pract Res Clin Rheumatol. 2012 Oct;26(5):649-58. doi: 10.1016/j.berh.2012.07.013.
- Background: PubMed 23948824Chong T, Don DW, Kao MC, Wong D, Mitra R. The value of physical examination in the diagnosis of hip osteoarthritis. J Back Musculoskelet Rehabil. 2013;26(4):397-400. doi: 10.3233/BMR-130398.
- Background: PubMed 27026818de Sa D, Phillips M, Catapano M, Simunovic N, Belzile EL, Karlsson J, Ayeni OR. Adhesive capsulitis of the hip: a review addressing diagnosis, treatment and outcomes. J Hip Preserv Surg. 2015 Nov 27;3(1):43-55. doi: 10.1093/jhps/hnv075. eCollection 2016 Apr.
- Background: PubMed 1613709Ike RW, Arnold WJ, Rothschild EW, Shaw HL. Tidal irrigation versus conservative medical management in patients with osteoarthritis of the knee: a prospective randomized study. Tidal Irrigation Cooperating Group. J Rheumatol. 1992 May;19(5):772-9.
- Background: PubMed 8452573Chang RW, Falconer J, Stulberg SD, Arnold WJ, Manheim LM, Dyer AR. A randomized, controlled trial of arthroscopic surgery versus closed-needle joint lavage for patients with osteoarthritis of the knee. Arthritis Rheum. 1993 Mar;36(3):289-96. doi: 10.1002/art.1780360302.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme Ocampos, MD principal investigator
University of São Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine and Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine, in people with Hip Osteoarthritis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Livia Abreu (1126612473, murmedicina@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018690, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.