Intra-articular Sodium Hyaluronate Injection after Arthroscopic Débridement for Osteoarthritis of the Knee: A Prospective, Randomized, Controlled Study

The effects of intra-articular Sodium Hyaluronate Injection after Arthroscopic Débridement for Osteoarthritis of the Knee evaluated by pain and physical scales: A Prospective, Randomized, Controlled Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000195358

Enrollment

Registered

2008-04-14

Start date

2004-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Arthroscopic débridement and hyaluronan injections are two different interventions to treat knee osteoarthritis. Arthroscopic débridement, although controversial, is a common practice among orthopaedic surgeons in the treatment of knee osteoarthritis. There is evidence on the potential benefits of the use of Hyaluronan for knee osteoarthritis. We aimed to assess the further potential benefits of using Hyaluronan as an adjunctive therapy after arthroscopic débridement. In addition our control group (only arthroscopy) was aimed to give information on the benefits of only arthroscopic intervention.

Interventions

The treatment course consisted of a continued series of three intra-articular injections of sodium hyaluronate (Orthovisc) administered during 3 consecutive weeks starting 3-weeks postoperatively (40 patients) into the affected (arthroscopied) knee joint. The HA used in this study was Orthovisc®, (30 mg sodium hyaluronate dissolved in 2 ml physiological saline; Anika Therapeutics Inc., Woburn, MA, USA).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Healthy volunteers

Inclusion criteria

age between 40-65 years, symptomatic primary knee OA according to American College of Rheumatology criteria with a Kellgren-Lawrence (K-L) severity grade of level II or III as determined radiographically at screening.

Exclusion criteria

• Patients who refused to provide the written informed consent for taking part in the study, agreed to follow study procedures and attend all study visits. • Patients with previously known bleeding diathesis or coagulation disorder, • Patients who have any form of contraindication for an arthroscopy procedure, • Patients with known allergies against chicken or chicken products for intra-articular sodium hyaluronate injection, • Patients with secondary arthritis, like rheumatoid arthritis or suspected to have any other form of an inflammatory arthritis, • Patients in whom “microfracture” technique was used during AD, • Patients with major frontal plane deformities, • Patients with patellar disorder or quadriceps mechanism disorders, • Patients with advanced level of mental handicap preventing them from fulfilling the study requirements.

Outcome results