This randomized trial was conducted on 90 patients with Osteoarthritis of the knee. People with knee Osteoarthritis were included and people with bilateral knee surgery, drug addicts, need for blood transfusions before surgery and had a knee infection were excluded from the study. Patients were divided into two groups of 45 people, in the intervention group, surgery was performed Kinematic align and in the control group, surgery was performed Mechanical align. This study was conducted during the years 1391 to 1392 which then patients were followed up 1 to 3 years. Postoperative pain, day hospitalization, patient satisfaction with the surgery, knee range of motion and hemoglobin before and after surgery was measured and after a year of surgery for patients completed Lyshlom knee scoring scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303286497N4
Registration date:2015-07-24, 1394/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Mahmood Karimi Mobarakeh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1272 2988
Email address
m_karimi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison results of Kinematic align and Mechanical align knee arthroplasty in patients with osteoarthritis
Public title
Comparison results of the Kinematic and Mechanical align in the total knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients diagnosed with Osteoarthritis of the knee joint with the informed consent
Exclusion criteria: Patients who need blood transfusions before surgery; Bilateral knee surgery; Knee infection; Fracture during surgery were requiring fixation; Patients with charcot joint; Drug addict
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman Medical University of Ethics Committee
Street address
Jomhoori Islami Boulvard
City
Kerman
Postal code
7519813159
Approval date
2013-06-06, 1392/03/16
Ethics committee reference number
92/316/K
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M25.7
ICD-10 code description
Osteophyte
Primary outcomes
1
Description
Hemoglobin
Timepoint
Before and after surgery
Method of measurement
Recorded from File
2
Description
Days of hospitalization
Timepoint
post operation
Method of measurement
Questionnaire
3
Description
Pain
Timepoint
Post operation
Method of measurement
Visual Analg Scale
4
Description
Satisfaction
Timepoint
One year after operation
Method of measurement
Question of patient
5
Description
Time abandon the Waker and driving
Timepoint
One year after operation
Method of measurement
Question of patient
6
Description
Duration of surgery
Timepoint
Post operation
Method of measurement
Recorded from File
7
Description
knee score
Timepoint
One year after surgery
Method of measurement
Lyshlom score
Secondary outcomes
1
Description
Side effects
Timepoint
One year after surgery
Method of measurement
Recorded from file
Intervention groups
1
Description
Kinematic align Knee arthroplasty in the intervention Which is less soft tissue release
Category
Treatment - Surgery
2
Description
Mechanical align knee arthroplasty in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mahmood Karimi Mobarke
Street address
Shafa Street, Kerman, Iran
City
Kerman
2
Recruitment center
Name of recruitment center
Razeea Firous Hospital
Full name of responsible person
Mahmood Karimi Mobarke
Street address
MotaharyStreet, Kerman, Iran
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Ibn Sina Street, Somayeh Crossroads
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahmood Karimi Mobarakeh
Position
Associated Professor
Other areas of specialty/work
Street address
Street Gharani, shahid Bahonar hospitals
City
Kerman
Postal code
751437896543098
Phone
+98 34327229
Fax
+98 34327229
Email
drkarimi_m@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahmood Karimi Mobarakeh
Position
Associated Professor
Other areas of specialty/work
Street address
Street Gharani, shahid Bahonar Hospital
City
Kerman
Postal code
751437896543098
Phone
+98 34327229
Fax
+98 34327229
Email
drkarimi_m@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahmood Karimi Mobarke
Position
Associatd Professor
Other areas of specialty/work
Street address
Street Gharani, shahid Bahonar hospitals
City
Kerman
Postal code
751437896543098
Phone
+98 34327229
Fax
+98 34327229
Email
drkarimi_m@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)