Effect of Interventions on the Progression of Knee Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02178137
• Date of registration: 27/06/2014
• Prospective Registration: No
• Primary sponsor: Indus Hospital
• Public title: Effect of Interventions on the Progression of Knee Osteoarthritis KAPS
• Scientific title: Effect of Interventions on Progression of Knee Osteoarthritis - a Comparison of Effect of Glucosamine/Chondroitin or Diacerin Vs Placebo: Measured by Clinical, Radiological and Biochemical Parameters
• Date of first enrolment: June 2014
• Target sample size: 322
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02178137
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Pakistan

Contacts

• Name: Mansoor A Khan, MBBS
• Affiliation: The Indus Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients of either sex aged between 40 to 65 years with mild to moderate
osteoarthritis of the knees.

- Patients should have history of knee pain for at least 6 months and on the majority of
days during the preceding month

- Each joint will be scored separately so one patient with bilateral knee osteoarthritis
will be counted as 2 knees.

- The osteoarthritis will be graded on basis of clinical score as well as seen on
appropriately positioned x rays using the Kellgren and Lawrence grading. (Tibio
femoral osteophytes of at least 1 mm, Kellgren Lawrence grading of 2 or 3)

- Patients with diabetes are sent to the diabetes clinic and are included once their
HbA1c level becomes normal.

- Patients giving Informed consent

Exclusion Criteria:

- Patients with severe end stage tricompartmental osteoarthritis of the knees .

- Presence of uncontrolled systemic disease like chronic liver and renal disease

- Patients with diagnosis other than osteoarthritis, such as knee arthritis due to
rheumatoid disease, gout, post traumatic arthritis

- Patients with history of surgery to any knee will have that knee excluded

- Pregnant or lactating mothers

- Patients with chronic anaemia

- Patients who get an injection in their affected knee



Age minimum: 40 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteo Arthritis of the Knees

Intervention(s)

Drug: Placebo

Drug: Diacerien

Drug: Glucosamine/Chondroitin

Primary Outcome(s)

Change to the SF-36 score at 24 months in comparison to baseline score [Time Frame: 24 months]

Change in WOMAC score at 24 months in comparison to baseline score [Time Frame: baseline, 24 months]

Mean differences in blood serum COMP levels of study arms [Time Frame: 24 months]

Secondary Outcome(s)

Change to the SF-36 score at 6 months in comparison to baseline score [Time Frame: 6 months]

Change in WOMAC score at 18 months in comparison to baseline score [Time Frame: 18 months]

Change in WOMAC score at 6 months in comparison to baseline score [Time Frame: 6 months]

Change to the SF-36 score at 12 months in comparison to baseline score [Time Frame: 12 months]

Change to the SF-36 score at 18 months in comparison to baseline score [Time Frame: 18 months]

Change in WOMAC score at 12 months in comparison to baseline score [Time Frame: 12 months]

Secondary ID(s)

TIH-Ortho-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors