Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis
NCT ID: NCT03089723
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-03-30
2019-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: To compare isolated lavage with lavage followed by injection of hyaluronic acid with mannitol into carpometacarpal osteoarthritis joint of the thumb.
METHODS: Forty joints of patients with multiple osteoarthritis (rhizoarthritis, including) and comorbidities (two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, hypertension) will be allocated into two groups: Lavage (LS) and Lavage and Injection Hilauronic acid (LO). Both groups will undergo joint lavage with saline solution. The LO group will receive the 20 mg / mL hilauronic acid injection with 5mg mannitol. Both groups will be guided in the clinical treatment of osteoarthritis and metabolic syndrome and will be given daily exercises for the hands. They will be evaluated with the quick DASH questionnaire, Sollerman Test and by measuring the palmar, lateral and pulp-pulp grip strength, in addition to measuring the ROM and VAS pain moments immediately prior to the procedure, one, three and six months after the articular procedure.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment and Comparison of Efficacy of Intra-Articular PRP and Corticosteroid in First CMC Joint OA Treatment
NCT06657300
Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis(GHOA)
NCT04949087
Single Blinded First CMC Osteoarthritis Treatment
NCT03196310
Effectiveness of Intra-articular Oxygen-ozone Injections and Splinting for the Treatment of Thumb Osteoarthritis
NCT07171840
Corticosteroid Intra-articular Injection in Hands Osteoarthritis
NCT02102620
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All patients are obliged to participate in a two-day education course on OA. During the program they are instructed about OA, metabolic syndrome, comorbidities and importance of diet, and daily exercise (including specific exercises for the hand).
After inclusion, 40 joints will be randomized in one of two treatment options, i.e., Lavage with saline solution and final injection of 1mL of saline solution, or lavage with saline solution followed by injection of 10mg of hyaluronic acid with mannitol (5mg).
After the procedure patients will receive naproxen 500mg twice daily for 5 days.
Patients will be instructed to exercise at least 180 minutes/week and if possible daily exercise for the hand (5 to 10 minutes daily).
Patients will be instructed to write down when and what they exercised as well as their daily medication intake (for co-morbidities and pain).
All patients will be submitted to pain (VAS), range of motion (ROM), Quick DASH, Sollermand Test and functional (palmar grip strength and lateral and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
As the assessments of pain, range of motion and strength will be compared with measurements of the same limb at inclusion, each hand involved of the patient will be considered as a case.
The "n" was calculated to obtain a statistical power of 80% and a level of significance of 5%. To do this, we considered the mean and standard deviation of the pulp-pulp pinch (our primary outcome) found in previous study of the prevalence of hand OA in individuals with knee osteoarthritis submitted to our educational program. A sample size was used to detect a variation of 1 point on the two-tailed pulp-pulp pinches. The sample size calculated by group was 16. Considering also possible faults and abandon of about 20% of the patients, the value of 20 patients per group was obtained.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lavage with Saline (LS)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
Visual Analog Scale (VAS)
Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months
Range of Motion (ROM)
submitted to ROM at at baseline, 1 month, 3 months and 6 months
Palmar grip strength
submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months
Lateral grip strength
submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months
Pulp-pulp pinch strength
submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months
Lavage with physiologic saline solution
Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.
Quick Dash
Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months
Sollerman Test
Perform Sollerman Test at baseline, 1 month, 3 months and 6 months
Lavage with Osteonil® Mini (LO)
Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.
Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
Visual Analog Scale (VAS)
Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months
Range of Motion (ROM)
submitted to ROM at at baseline, 1 month, 3 months and 6 months
Palmar grip strength
submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months
Lateral grip strength
submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months
Pulp-pulp pinch strength
submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months
Lavage with physiologic saline solution and Osteonil® Mini
Joint lavage with physiologic saline solution and Osteonil® Mini
Quick Dash
Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months
Sollerman Test
Perform Sollerman Test at baseline, 1 month, 3 months and 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Visual Analog Scale (VAS)
Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months
Range of Motion (ROM)
submitted to ROM at at baseline, 1 month, 3 months and 6 months
Palmar grip strength
submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months
Lateral grip strength
submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months
Pulp-pulp pinch strength
submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months
Lavage with physiologic saline solution
Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.
Lavage with physiologic saline solution and Osteonil® Mini
Joint lavage with physiologic saline solution and Osteonil® Mini
Quick Dash
Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months
Sollerman Test
Perform Sollerman Test at baseline, 1 month, 3 months and 6 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* CMC OA joint of the thumb stages I to III as classified by Eaton et al. (4)
Exclusion Criteria
* Not performing the exercises as instructed
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marcia Uchoa Rezende
MD; PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcia U Rezende, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopedics and Traumatology - HCFMUSP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kennedy CD, Manske MC, Huang JI. Classifications in Brief: The Eaton-Littler Classification of Thumb Carpometacarpal Joint Arthrosis. Clin Orthop Relat Res. 2016 Dec;474(12):2729-2733. doi: 10.1007/s11999-016-4864-6. Epub 2016 May 4. No abstract available.
Gillis J, Calder K, Williams J. Review of thumb carpometacarpal arthritis classification, treatment and outcomes. Can J Plast Surg. 2011 Winter;19(4):134-8. doi: 10.1177/229255031101900409.
Gehrmann SV, Tang J, Li ZM, Goitz RJ, Windolf J, Kaufmann RA. Motion deficit of the thumb in CMC joint arthritis. J Hand Surg Am. 2010 Sep;35(9):1449-53. doi: 10.1016/j.jhsa.2010.05.026.
Eaton RG, Lane LB, Littler JW, Keyser JJ. Ligament reconstruction for the painful thumb carpometacarpal joint: a long-term assessment. J Hand Surg Am. 1984 Sep;9(5):692-99. doi: 10.1016/s0363-5023(84)80015-5.
Matullo KS, Ilyas A, Thoder JJ. CMC arthroplasty of the thumb: a review. Hand (N Y). 2007 Dec;2(4):232-9. doi: 10.1007/s11552-007-9068-9. Epub 2007 Aug 7.
Diaconu M, Mathoulin C, Facca S, Liverneaux P. Arthroscopic interposition arthroplasty of the trapeziometacarpal joint. Chir Main. 2011 Sep;30(4):282-7. doi: 10.1016/j.main.2011.06.009. Epub 2011 Jul 19.
Vermeulen GM, Slijper H, Feitz R, Hovius SE, Moojen TM, Selles RW. Surgical management of primary thumb carpometacarpal osteoarthritis: a systematic review. J Hand Surg Am. 2011 Jan;36(1):157-69. doi: 10.1016/j.jhsa.2010.10.028.
Bell R, Desai S, House H, O'Donovan T, Palmer AK. A retrospective multicenter study of the Artelon(R) carpometacarpal joint implant. Hand (N Y). 2011 Dec;6(4):364-72. doi: 10.1007/s11552-011-9366-0. Epub 2011 Sep 24.
Badia A, Sambandam SN. Total joint arthroplasty in the treatment of advanced stages of thumb carpometacarpal joint osteoarthritis. J Hand Surg Am. 2006 Dec;31(10):1605-14. doi: 10.1016/j.jhsa.2006.08.008.
Sillem H, Backman CL, Miller WC, Li LC. Comparison of two carpometacarpal stabilizing splints for individuals with thumb osteoarthritis. J Hand Ther. 2011 Jul-Sep;24(3):216-25; quiz 126; discussion 227-30. doi: 10.1016/j.jht.2010.12.004. Epub 2011 Mar 21.
Valdes K, von der Heyde R. An exercise program for carpometacarpal osteoarthritis based on biomechanical principles. J Hand Ther. 2012 Jul-Sep;25(3):251-62; quiz 263. doi: 10.1016/j.jht.2012.03.008.
Clegg TE, Caborn D, Mauffrey C. Viscosupplementation with hyaluronic acid in the treatment for cartilage lesions: a review of current evidence and future directions. Eur J Orthop Surg Traumatol. 2013 Feb;23(2):119-24. doi: 10.1007/s00590-012-0940-0. Epub 2012 Jan 28.
Gigante A, Callegari L. The role of intra-articular hyaluronan (Sinovial) in the treatment of osteoarthritis. Rheumatol Int. 2011 Apr;31(4):427-44. doi: 10.1007/s00296-010-1660-6. Epub 2010 Nov 28.
Fakhari A, Berkland C. Applications and emerging trends of hyaluronic acid in tissue engineering, as a dermal filler and in osteoarthritis treatment. Acta Biomater. 2013 Jul;9(7):7081-92. doi: 10.1016/j.actbio.2013.03.005. Epub 2013 Mar 15.
Mei-Dan O, Carmont M, Laver L, Mann G, Maffulli N, Nyska M. Intra-articular injections of hyaluronic acid in osteoarthritis of the subtalar joint: a pilot study. J Foot Ankle Surg. 2013 Mar-Apr;52(2):172-6. doi: 10.1053/j.jfas.2012.12.008. Epub 2013 Jan 17.
de Campos GC, Rezende MU, Pailo AF, Frucchi R, Camargo OP. Adding triamcinolone improves viscosupplementation: a randomized clinical trial. Clin Orthop Relat Res. 2013 Feb;471(2):613-20. doi: 10.1007/s11999-012-2659-y. Epub 2012 Oct 26.
Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.
Frizziero A, Maffulli N, Masiero S, Frizziero L. Six-months pain relief and functional recovery after intra-articular injections with hyaluronic acid (mw 500-730 KDa) in trapeziometacarpal osteoarthritis. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):256-61. eCollection 2014 Apr.
Bahadir C, Onal B, Dayan VY, Gurer N. Comparison of therapeutic effects of sodium hyaluronate and corticosteroid injections on trapeziometacarpal joint osteoarthritis. Clin Rheumatol. 2009 May;28(5):529-33. doi: 10.1007/s10067-008-1079-6. Epub 2009 Jan 10.
Kroon FP, Rubio R, Schoones JW, Kloppenburg M. Intra-Articular Therapies in the Treatment of Hand Osteoarthritis: A Systematic Literature Review. Drugs Aging. 2016 Feb;33(2):119-33. doi: 10.1007/s40266-015-0330-5.
Campos GC, Kohara MT, Rezende MU, Santana OF, Moreira MM, Camargo OP. Schooling of the patients and clinical application of questionnaires in osteoarthitis. Acta Ortop Bras. 2014;22(5):256-9. doi: 10.1590/1413-78522014220500980.
de Rezende MU, Hissadomi MI, de Campos GC, Frucchi R, Pailo AF, Pasqualin T, Brito NL, Santana OF, Moreira MM, Strutz CG, Matos NB, de Camargo OP, Hernandez AJ. One-Year Results of an Educational Program on Osteoarthritis: A Prospective Randomized Controlled Trial in Brazil. Geriatr Orthop Surg Rehabil. 2016 Jun;7(2):86-94. doi: 10.1177/2151458516645634. Epub 2016 May 11.
Mendoza G, Alvarez AI, Pulido MM, Molina AJ, Merino G, Real R, Fernandes P, Prieto JG. Inhibitory effects of different antioxidants on hyaluronan depolymerization. Carbohydr Res. 2007 Jan 15;342(1):96-102. doi: 10.1016/j.carres.2006.10.027. Epub 2006 Nov 2.
Vad VB, Bhat AL, Sculco TP, Wickiewicz TL. Management of knee osteoarthritis: knee lavage combined with hylan versus hylan alone. Arch Phys Med Rehabil. 2003 May;84(5):634-7. doi: 10.1016/s0003-9993(02)04811-6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14733/16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.