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RhizarthrosisNCT03089723

Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis

A study testing Visual Analog Scale (VAS), Range of Motion (ROM) and Palmar grip strength in people with Rhizarthrosis and Metabolic Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Rhizarthrosis, Metabolic Disease
What is being tested?
Visual Analog Scale (VAS), Range of Motion (ROM) and Palmar grip strength
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
30 Mar 2017to 30 Aug 2019
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • Missing classes or functional evaluations
  • Not performing the exercises as instructed

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Instituto de Ortopedia e Traumatologia

    São Paulo, São Paulo, 05403010

Other trials in Brazil

About this study

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.

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.

Read the detailed 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.

Being tested
Visual Analog Scale (VAS), Range of Motion (ROM), Palmar grip strength, Lateral grip strength, Pulp-pulp pinch strength
Keywords
carpometacarpal joint ostearthritis, hyaluronic acid, Rhizarthrosis
Medical subject headings
Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual Analog Scale (VAS)Behavioural

    Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months

  • Range of Motion (ROM)Behavioural

    submitted to ROM at at baseline, 1 month, 3 months and 6 months

  • Palmar grip strengthBehavioural

    submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months

  • Lateral grip strengthBehavioural

    submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months

  • Pulp-pulp pinch strengthBehavioural

    submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months

  • Lavage with physiologic saline solutionDrug

    Also called Lavage with Saline (LS)

    Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.

  • Lavage with physiologic saline solution and Osteonil® MiniDrug

    Also called Lavage with Osteonil® Mini (LO)

    Joint lavage with physiologic saline solution and Osteonil® Mini

  • Quick DashBehavioural

    Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months

  • Sollerman TestBehavioural

    Perform Sollerman Test at baseline, 1 month, 3 months and 6 months

Study groups in NCT03089723
Study groupRoleWhat they receive
Lavage with Saline (LS)ExperimentalUnder 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.
Receives: Behavioral: Visual Analog Scale (VAS); Behavioral: Range of Motion (ROM); Behavioral: Palmar grip strength; Behavioral: Lateral grip strength; Behavioral: Pulp-pulp pinch strength; Drug: Lavage with physiologic saline solution; Behavioral: Quick Dash; Behavioral: Sollerman Test
Lavage with Osteonil® Mini (LO)ExperimentalUnder 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.
Receives: Behavioral: Visual Analog Scale (VAS); Behavioral: Range of Motion (ROM); Behavioral: Palmar grip strength; Behavioral: Lateral grip strength; Behavioral: Pulp-pulp pinch strength; Drug: Lavage with physiologic saline solution and Osteonil® Mini; Behavioral: Quick Dash; Behavioral: Sollerman Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in grip strength at 6 months

    Perform test and collected data in baseline, 1 month, 3 months and 6 months.

    Measured: Baseline, 1 month, 3 months and 6 months.

Secondary outcomes (5)

  1. Assess improvement in pain

    Answer VAS (Visual Analog Scale)

    Measured: Baseline, 1 month, 3 months and 6 months.

  2. Assess improvement in range of motion

    Measure range of motion

    Measured: Baseline, 1 month, 3 months and 6 months.

  3. Assess improvement in palmar grip strength

    Perform palmar grip strength

    Measured: Baseline, 1 month, 3 months and 6 months.

  4. Assess improvement in lateral pinch strength.

    Perform lateral pinch strength.

    Measured: Baseline, 1 month, 3 months and 6 months.

  5. Assess improvement in Pulp-pulp pinch strength

    Perform pulp-pulp pinch strength

    Measured: Baseline, 1 month, 3 months and 6 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start30 Mar 2017
  3. Primary completion30 Mar 2018
  4. Study completion30 Aug 2019 (estimated)

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089723
Sponsor's protocol ID
14733/16
Status last verified
May 2019
First submitted
12 Jan 2017
Last updated
16 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27146653

  • 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.

    PubMed 23204884

  • 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.

    PubMed 20807622

  • 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.

    PubMed 6491213

  • 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.

    PubMed 18780059

  • 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.

    PubMed 21816649

  • 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.

    PubMed 21193136

  • 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.

    PubMed 23204961

  • 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.

    PubMed 17145380

  • 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.

    PubMed 21420278

  • 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.

    PubMed 22794499

  • 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.

    PubMed 23412441

  • 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.

    PubMed 21113807

  • 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.

    PubMed 23507088

  • 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.

    PubMed 23333279

Questions about this trial

What is this clinical trial studying?

A study testing Visual Analog Scale (VAS), Range of Motion (ROM) and Palmar grip strength in people with Rhizarthrosis and Metabolic Disease, 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 2 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 16 May 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in grip strength at 6 months (time frame: Baseline, 1 month, 3 months and 6 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 NCT03089723, which also lists 24 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 16 May 2019.

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Clinical Trial NCT03089723 | AzTrials