Clinical trial NCT03783455: Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis
Official title: Assessment of Short-term Effectiveness of Five Local Treatment Modalities in Patients With Symptomatic Knee Osteoarthritis: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Corticosteroid
Hyaluronic acid
Joint Lavage
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open, controlled, randomized and prospective study.
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Current medical treatment strategies for knee osteoarthritis (OA) are aimed at pain reduction and symptom control. The Non-Arthroscopic Joint Lavage (NAJL) is included inside the therapeutic algorithm of knee OA when other therapies are contraindicated or have lost effectiveness. The large variety of potentially invasive interventions available (joint lavage included) has raised the need to assess their efficacy. The objective of this study is to compare the short-term effectiveness of five treatment strategies in patients with knee osteoarthritis (OA).

METHODS: It was conducted a randomized prospective study involving 150 patients of whom 76.7% were females. The age range was 40-81 years. All patients had knee OA according to the American College of Rheumatology criteria, with Kellgren-Lawrence radiographic grades II and III. Patients were assigned to five groups, 1) non-arthroscopic joint lavage (NAJL) (n= 30), 2) NAJL plus hyaluronic acid (HA) (n= 32), 3) NAJL plus corticosteroid (CS) (n= 32), 4) HA (n= 31), 5) CS (n= 25). Evaluations took place at baseline, one and three months after enrollment. Demographic variables, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Lequesne scores were recorded. Statistical analysis included mixed analysis of variance, post-hoc comparisons with Sidak's adjustment, and multiple linear regression using as outcome WOMAC total at 3 months.

TRIAL REGISTRATION: The protocol of the study was approved by the "Hospital Universitario Reina Sofía" Ethics Committee, under the number 1996, in the Minutes 208 of 29 May 2012.


Eligibility criteria: Inclusion Criteria:

* Meeting American College of Rheumatology (ACR) criteria for knee OA, symptoms for at least three months despite conservative medical treatment, knee OA grade II or III on the radiological Kellgren-Lawrence scale, and voluntary collaboration.

Exclusion Criteria:

* ankylosis of joint;
* total arthroplasty or previous osteotomy
* infected injury;
* treatment with dicumarinic drugs or alterations in blood coagulation,
* venous insufficiency or episode of venous thrombosis;
* administration of hyaluronic acid (HA) in the previous year, and/or corticosteroid (CS) infiltration or NAJL in the previous three months.

Primary outcomes:
measure: WOMAC 3.1 Index total
timeFrame: WOMAC total at 3 months
Secondary outcomes:
measure: Lequesne Index
timeFrame: baseline, at one month and at three months
measure: WOMAC 3.1 Index pain
timeFrame: WOMAC pain at baseline
measure: WOMAC 3.1 Index pain
timeFrame: WOMAC pain at one month
measure: WOMAC 3.1 Index pain
timeFrame: WOMAC pain at three months
measure: WOMAC 3.1 Index function
timeFrame: WOMAC function at baseline
measure: WOMAC 3.1 Index function
timeFrame: WOMAC function at one month
measure: WOMAC 3.1 Index function
timeFrame: WOMAC function at three months
measure: WOMAC 3.1 Index stiffness
timeFrame: WOMAC stiffness at baseline
measure: WOMAC 3.1 Index stiffness
timeFrame: WOMAC stiffness at one month
measure: WOMAC 3.1 Index stiffness
timeFrame: WOMAC stiffness at three months
measure: WOMAC 3.1 Index total
timeFrame: WOMAC total at baseline
measure: WOMAC 3.1 Index total
timeFrame: WOMAC total at one month
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Lourdes Ladehesa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cope PJ, Ourradi K, Li Y, Sharif M. Models of osteoarthritis: the good, the bad and the promising. Osteoarthritis Cartilage. 2019 Feb;27(2):230-239. doi: 10.1016/j.joca.2018.09.016. Epub 2018 Oct 25.
citation: Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
citation: Cooper C, Rannou F, Richette P, Bruyere O, Al-Daghri N, Altman RD, Brandi ML, Collaud Basset S, Herrero-Beaumont G, Migliore A, Pavelka K, Uebelhart D, Reginster JY. Use of Intraarticular Hyaluronic Acid in the Management of Knee Osteoarthritis in Clinical Practice. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1287-1296. doi: 10.1002/acr.23204. Epub 2017 Aug 8. No abstract available.
citation: Escobar A, Quintana JM, Bilbao A, Azkarate J, Guenaga JI. Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clin Rheumatol. 2002 Nov;21(6):466-71. doi: 10.1007/s100670200117.