Clinical trial NCT03937518: Strontium Ranelate and KOA
Official title: Strontium Ranelate as New Modality in Treatment of Primary Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation

Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:

Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08. Inclusion

Detailed description: The present study was carried out on thirty patients with primary knee osteoarthritis. Patients were recruited from Rheumatology and Rehabilitation

Outpatient Clinic at Mansoura University Hospi Patients were divided into two groups:

Group 1: included 15 patients who received oral strontium ranelate and physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 11 females and 4 males. Group 2: included 15 patients who received physiotherapy program. The age of the patients ranged from 50 to 62 years, they were 12 females and 3 males. Written consent was obtained from each participant sharing in the study. This study was approved by the institution research board of faculty of medicine, Mansoura University, code: MS/15.10.08.

InclusionAll patients were subjected to the following:

I. History Taking :

1. Personal History

   * Name, age, sex, residence, marital status.
   * Occupational status.
   * Special habits e.g. smoking status (current/previous).
2. Complaint:

   Taken in the patient's own words with special stress on disease duration.
3. Present history:

   Onset, course and duration of disease. Analysis of complaint Pain: type of pain, site of pain, factors participating/alleviating pain. Swelling. Crepitus. Limitation of movement. Morning and inactivity stiffness, its duration and location. Other joints affected and its pattern of distribution.

   History of other systems affections:

   Neurological symptoms (muscle power and sensation of the lower limbs). Eye symptoms (redness, ulcers and blurred vision). Gastrointestinal tract (GIT) symptoms (diarrhea, heart burn and mucus in the stool). Urinary tract (UT) symptoms (dysuria and frequency). Skin affection (ulcers, erythema, papules and nodules).
4. Past history:

History of surgical operation of knee.

HistoryAssessment of range of motion of the affected knee joint:

For any limitation in the range of motion of the knee joint.

D) Special tests to assess ligaments and menisci:

Varus stress test for lateral collateral ligament. Valgus stress test for medial collateral ligament. Anterior drawer test for anterior cruciate ligament. Posterior drawer test for posterior cruciate ligament.

McMurry's test for menisci.Radiological investigations:

Eligibility criteria: Inclusion Criteria:

Patients aged ≥ 40 years with symptoms of knee osteoarthritis

Exclusion Criteria:

rheumatoid arthritis, spondyloarthropathy

Primary outcomes:
measure: change of pain from base line
timeFrame: immediately before intervention,3 monthes after intervention,6 monthes after intervention
Secondary outcomes:
measure: change of function from base line
timeFrame: immediately before intervention,3 monthes after intervention,6 monthes after intervention
measure: change of MRI findings from base line
timeFrame: immediately before intervention and 6 monthes after intervention
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Uninersity Faculty of Medicine
state: Dakahlia Provence
Study officials:
References: