Oxaceprol versus tramadol in knee osteoarthritis

Phase 4

Conditions: Health Condition 1: null- Primary osteoarthritis of the knee, either unilateral or bilateral

Registration Number: CTRI/2014/08/004821

Lead Sponsor: Institute of Postgraduate Medical Education Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Clinically diagnosed cases of primary symptomatic OA affecting at least one knee joint (in case of bilateral knee involvement, the more symptomatic knee will be scored as the â??signal kneeâ??) fulfilling the following:

•Age: Above 50 years

•Sex: Either sex will be included

•Knee joint pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min OR knee crepitus

•Knee pain on movement of intensity at least 35 mm on a 100 mm VAS (Visual Analogue Score) scale.

Exclusion Criteria

•Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Pagetâ??s disease, hemophilia etc.

•Non-OA causes of knee pain in the signal knee (e.g. bursitis, fibromyalgia, osteonecrosis etc)

•Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months.

•Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrollment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at anytime.

•Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year.

•Serious concomitant disease.

•Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrollment of a particular subject into the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of oxaceprol in symptomatic primary osteoarthritis of the kneeTimepoint: Screening visit, baseline visit, follow up visit at 4th, 8th and 12th week

Secondary Outcome Measures