The MEBAGA” study

Completed

• Conditions: The required study population was patients affected by gonarthrosis; Musculoskeletal Diseases; Gonarthrosis (arthrosis of knee)

• Registration Number: ISRCTN14885594
• Lead Sponsor: aborest Spa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-04
• Last Update Posted: 6 July 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Men and women >25 and <86 years of age
2. A diagnosis of OA of the knee according to the criteria of the American College of Rheumatology
3. Grade 3 Kellgren and Lawrence radiographic staging, in which the severity of the arthritis is assessed on a scale from 0-4, hypothesizing a sequential evolution from the manifestation of osteophytes through a reduction in the width of the joint space, to subchondral sclerosis and ?nally the formation of cysts
4. Frequent joint pain (several days a week) for at least 6 months before recruitment;
5. Pain in the knee, scored at least 2 cm on a 10 centimetric visual analogic scale (VAS), where 0 means no pain and 10 is the worst pain possible;
6. A score of >2 on the Lequesne pain-function index (LI). The LI is a disease-specific validated questionnaire that poses a series of questions about pain in the knee (five questions on a scale from 0 to 2, where 0 indicates no pain and 2 intense pain), functional limitation (four questions, using the same scale) and maximum walking distance (one question, with a score from 0 to 6, where 0 indicates the ability to walk for an unlimited distance and 6, the inability to cover 100 m). The maximum worst ?nal score is 24.
Lack of symptoms in other joints was not taken into consideration.

Exclusion Criteria

1. Previous surgery of the affected knee
2. Disease processes such as rheumatoid arthritis, autoimmune diseases, systemic diseases, and tumors
3. Severe obesity (BMI >40 kg/m2)
4. Allergy to shellfish
5. Altered blood chemistry and kidney, liver, and metabolic (diabetes mellitus) function;
6. Intra-articular hyaluronic acid/cortisone infiltrations to the affected knee within 3 months before the start of the study
7. Systemic cortisone treatment taken within 3 months before the start of the study
8. Supplements (glucosamine, chondroitin sulfate, bromeline, etc) taken within 3 months before the start of the study (patients were also informed that they were not to be taken for the following 6 months).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment, de?ned as a decrease of pain on the VAS and an improvement in the patient’s global assessment score on the LEQUESNE INDEX from baseline at 2 and at 6 months.

Secondary Outcome Measures

Name	Time	Method
Reduction in the patients’ need to take anti-inflammatory drugs at 2 and 6 months. All analyses were performed at each FU, comparing results within each group and between the two groups.