Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis

Metabolic Disease Clinical Trial

Official title:

Comparative Study of the Intraarticular Treatment of Carpometacarpal Joint Ostearthritis of the Thumb With Lavage With Saline Solution, or Lavage and Injection of Hyaluronic Acid and Mannitol.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03089723
• Other study ID #: 14733/16
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although a common problem, hand osteoarthritis (HOA) is less studied than knee and hip. In the age group of 71-100 years, the prevalence of symptomatic HOA reaches 26% of women and 13% of men. These patients lose hand strength and have difficulty with day-to-day manual activities. The main joints involved are the proximal and distal interphalangeals and the carpometacarpal joint of the thumb. In the educational Project PARQVE, the prevalence of HOA was 23.7% at inclusion in the program, and 47.4% after one year, with loss of grip strength. There is controversy over the effect of viscosupplementation in the treatment of rhizarthritis when considering pain. However, strength is a very important function parameter that must be evaluated for function and quality of life maintenance. Concerned about the importance of maintaining strength and function in our program (PARQVE), we have added specific exercises tom improve hand strength and range of motion. Trying to optimize the treatment and confronting questions about the effect of the joint wash, called placebo in the comparative studies with corticosteroid and/or hyaluronic acid injection, we did a work where all the patients will be washed with physiological saline solution but a group, after emptying, will receive 1mL of hyaluronic acid with mannitol.

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.

Description:

Patients with multiple osteoarthritis (including carpometacarpal joint of the thumb, stages I to III - Eaton et al.) in treatment at the Institute of Orthopedics and Traumatology fo the Clinics Hospital - University of São Paulo (IOT-HC-FMUSP) will be invited to participate in this study.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 30, 2019
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women diagnosed with multiple arthritis (including CMC OA of the thumb) with comorbidities (metabolic syndrome, i.e., OA and overweight / obesity, and/or hyperglycemia, and/or dyslipidemia, and/or hyperuricemia, and/or hypertension).

• CMC OA joint of the thumb stages I to III as classified by Eaton et al. (4)

Exclusion Criteria:

• Missing classes or functional evaluations

• Not performing the exercises as instructed

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Rhizarthrosis

Intervention

Behavioral:
• 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

Drug:
• 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

Behavioral:
• 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

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (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. — View Citation

Bahadir C, Onal B, Dayan VY, Gürer 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. — View Citation

Bell R, Desai S, House H, O'Donovan T, Palmer AK. A retrospective multicenter study of the Artelon® carpometacarpal joint implant. Hand (N Y). 2011 Dec;6(4):364-72. doi: 10.1007/s11552-011-9366-0. Epub 2011 Sep 24. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Rheumatol Int. 2011 Jul;31(7):981. Dosage error in article text. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2016 May 4. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Nov 2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in grip strength at 6 months	Perform test and collected data in baseline, 1 month, 3 months and 6 months.	Baseline, 1 month, 3 months and 6 months.
Secondary	Assess improvement in pain	Answer VAS (Visual Analog Scale)	Baseline, 1 month, 3 months and 6 months.
Secondary	Assess improvement in range of motion	Measure range of motion	Baseline, 1 month, 3 months and 6 months.
Secondary	Assess improvement in palmar grip strength	Perform palmar grip strength	Baseline, 1 month, 3 months and 6 months.
Secondary	Assess improvement in lateral pinch strength.	Perform lateral pinch strength.	Baseline, 1 month, 3 months and 6 months.
Secondary	Assess improvement in Pulp-pulp pinch strength	Perform pulp-pulp pinch strength	Baseline, 1 month, 3 months and 6 months.