Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Osteo Arthritis Knee

Treatments: Procedure: Intraarticular injection of corticosteroid; Procedure: Intraarticular injection of hyaluronic acid; Procedure: Non arthroscopic joint lavage plus corticosteroid; Procedure: Non arthroscopic joint lavage; Procedure: Non arthroscopic joint lavage plus hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03783455

NAJL

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 5 patient groups

Non arthroscopic joint lavage (NAJL)

Active Comparator group

Description:

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.

Treatment:

Procedure: Non arthroscopic joint lavage

Non arthroscopic joint lavage plus corticosteroid

Active Comparator group

Description:

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.

Treatment:

Procedure: Non arthroscopic joint lavage plus corticosteroid

Non arthroscopic joint lavage plus hyaluronic acid

Active Comparator group

Description:

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.

Treatment:

Procedure: Non arthroscopic joint lavage plus hyaluronic acid

Intraarticular injection of hyaluronic acid

Active Comparator group

Description:

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.

Treatment:

Procedure: Intraarticular injection of hyaluronic acid

Intraarticular injection of corticosteroid

Active Comparator group

Description:

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.

Treatment:

Procedure: Intraarticular injection of corticosteroid