Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

Assessment of Short-term Effectiveness of Five Local Treatment Modalities in Patients With Symptomatic Knee Osteoarthritis: a Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783455
• Other study ID #: NAJL
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: December 2018
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Non arthroscopic joint lavage
Instillation of 4 litters of cold physiological serum
• Non arthroscopic joint lavage plus corticosteroid
Instillation of 4 litters of cold physiological serum followed by intraarticular injection of triamcinolone
• Non arthroscopic joint lavage plus hyaluronic acid
Instillation of 4 litters of cold physiological serum followed by intraarticular injection of hyaluronic acid
• Intraarticular injection of corticosteroid
Intraarticular injection containing 40 mg of triamcinolone acetonide.
• Intraarticular injection of hyaluronic acid
Intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

References & Publications (4)

Cooper C, Rannou F, Richette P, Bruyère 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. Review. — View Citation

Cope PJ, Ourradi K, Li Y, Sharif M. Models of osteoarthritis: the good, the bad and the promising. Osteoarthritis Cartilage. 2018 Oct 25. pii: S1063-4584(18)31507-3. doi: 10.1016/j.joca.2018.09.016. [Epub ahead of print] Review. — View Citation

Escobar A, Quintana JM, Bilbao A, Azkárate J, Güenaga 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC 3.1 Index total	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC total at 3 months
Secondary	Lequesne Index	Lequesne Index is a ten question questionnaire that asseses pain and function in patients with osteoarthritis of the knee. It is composed by five questions about pain, being three of them from 0 to 2, and two of them from 0 to 1 point, two questions about maximum distance walked (from 0 to 6 points one and from 0 to 2 the second) and four questions about activities of daily living (from 0 to 2). The total values is the sum of all questions points and range from 1 to 24, being 1-4 mild handicap, 5-7 moderate, 8-10 severe, 11-13 very severe, and >14 extremely severe handicap.	baseline, at one month and at three months
Secondary	WOMAC 3.1 Index pain	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC pain at baseline
Secondary	WOMAC 3.1 Index pain	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC pain at one month
Secondary	WOMAC 3.1 Index pain	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC pain at three months
Secondary	WOMAC 3.1 Index function	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC function at baseline
Secondary	WOMAC 3.1 Index function	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC function at one month
Secondary	WOMAC 3.1 Index function	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC function at three months
Secondary	WOMAC 3.1 Index stiffness	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC stiffness at baseline
Secondary	WOMAC 3.1 Index stiffness	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC stiffness at one month
Secondary	WOMAC 3.1 Index stiffness	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC stiffness at three months
Secondary	WOMAC 3.1 Index total	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC total at baseline
Secondary	WOMAC 3.1 Index total	The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. In the study it was used the validated Spanish version of the 5-point adjectival scale format (possible answers are none -0 points-, slight -1 point-, moderate -2 points-, severe -3 points- and extreme -4 points-). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.	WOMAC total at one month