Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis
NCT ID: NCT03783455
Last Updated: 2018-12-21
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
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COMPLETED
NA
150 participants
INTERVENTIONAL
2015-09-01
2016-06-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non arthroscopic joint lavage (NAJL)
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution, followed by an injection of local anesthetic (5 mL of 2% mepivacaine hydrochloride) into the outer mediopatellar zone. The anesthetic was allowed to act, and an access way was then opened with a No. 16 abocat. Any effusion in the joint was drained. Then, approximately 100 mL of cold saline was instilled through the outer access way. Once the knee was distended, a further 5 mL of local anesthetic was injected into the inner mediopatellar zone, and a new abocat guide was used to establish the inner drainage way. The lavage proper involved instillation of 4 L of cold (8ºC) saline at a constant flow-rate using a dropper line connected to the entry way; the inner zone was also connected to another, free-fall dropper.
Non arthroscopic joint lavage
Instillation of 4 litters of cold physiological serum
Non arthroscopic joint lavage plus corticosteroid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution, followed by an injection of local anesthetic (5 mL of 2% mepivacaine hydrochloride) into the outer mediopatellar zone. The anesthetic was allowed to act, and an access way was then opened with a No. 16 abocat. Any effusion in the joint was drained. Then, approximately 100 mL of cold saline was instilled through the outer access way. Once the knee was distended, a further 5 mL of local anesthetic was injected into the inner mediopatellar zone, and a new abocat guide was used to establish the inner drainage way. The lavage proper involved instillation of 4 L of cold (8ºC) saline at a constant flow-rate using a dropper line connected to the entry way; the inner zone was also connected to another, free-fall dropper. Following administration of the joint lavage, the NAJL plus corticosteroid group was given an intra-articular injection containing 40 mg of triamcinolone acetonide.
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
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution, followed by an injection of local anesthetic (5 mL of 2% mepivacaine hydrochloride) into the outer mediopatellar zone. The anesthetic was allowed to act, and an access way was then opened with a No. 16 abocat. Any effusion in the joint was drained. Then, approximately 100 mL of cold saline was instilled through the outer access way. Once the knee was distended, a further 5 mL of local anesthetic was injected into the inner mediopatellar zone, and a new abocat guide was used to establish the inner drainage way. The lavage proper involved instillation of 4 L of cold (8ºC) saline at a constant flow-rate using a dropper line connected to the entry way; the inner zone was also connected to another, free-fall dropper. Following administration of the joint lavage, the patients were given an intra-articular injection containing 4 ml of a bioengineered hyaluronic acid.
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 hyaluronic acid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution. This was followed by an intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.
Intraarticular injection of hyaluronic acid
Intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.
Intraarticular injection of corticosteroid
Establishment of sterile areas and cleaning of the skin around the knee with a povidone-iodine solution. This was followed by an intraarticular injection containing 40 mg of triamcinolone acetonide.
Intraarticular injection of corticosteroid
Intraarticular injection containing 40 mg of triamcinolone acetonide.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Maimónides Biomedical Research Institute of Córdoba
OTHER
Responsible Party
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Principal Investigators
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Lourdes Ladehesa, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Reina Sofía
References
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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.
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.
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.
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.
Other Identifiers
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NAJL
Identifier Type: -
Identifier Source: org_study_id