In this study, we evaluated the clinical outcomes of total knee arthroplasty after proximal tibial osteotomy as the case group and primary total knee arthroplasty as the control group in the patients with medial compartment osteoarthritis of the knee in Rasule-Akram hospital. The control group was constructed to be matched in terms of age, gender, and etiology with the case group. 38 patients (41 knees) went under total knee arthroplasty due to unsuccessful proximal tibial osteotomy as the case group and 42 patients (43 knees) underwent the primary total knee arthroplasty as the control group. This study was carried out during 2004 and 2008 on the patients above 18 years old and without a history of previous knee arthroplasty, who were suffering from severe pain or progressive osteoarthritis which made them candidates to total knee arthroplastic surgery. All the patients were followed for at least 2 years. The evaluation was performed using Hospital for Special Surgery Rating Scale (HSS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902053011N1
Registration date:2010-05-22, 1389/03/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-22, 1389/03/01
Registrant information
Name
Ehsan Akbarian
Name of organization / entity
Department of Public Health Sciences, Karolinska Institutet
Country
Sweden
Phone
004685718204
Email address
ehsan.akbarian.983@student.ki.se
Recruitment status
Recruitment complete
Funding source
Rasoule Akram Hospital
Expected recruitment start date
2003-03-20, 1381/12/29
Expected recruitment end date
2006-03-20, 1384/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome evaluation of total knee arthroplasty among patients with and without previous high tibial osteotomy
Public title
Outcome evaluation of total knee arthroplasty among patients with and without previous high tibial osteotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: indication of performing total knee arthroplasty
Exclusion criteria: ages of below 18; history of previous total knee arthroplasty
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not 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
Research Committee of Rasoul-e-Akram Hospital
Street address
Sattarkhan Ave.
City
Tehran
Postal code
Approval date
2010-05-01, 1389/02/11
Ethics committee reference number
20826
Health conditions studied
1
Description of health condition studied
Knee arthrosis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
(HSS rating scale (hospital for special surgery
Timepoint
1 month post-op, 3 months after that and then every 6 months until 2 years postop
Method of measurement
HSS is evaluated according to pain, function, motion, muscular strength, flexion deformity, and instability.
Secondary outcomes
empty
Intervention groups
1
Description
total knee arthroplasty after osteotomy
Category
Treatment - Surgery
2
Description
primaty total knee arthroplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram General Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasoule Akram Hospital, Orthopedics ward
Full name of responsible person
Dr Hossein Farahini
Street address
Niayesh st., Sattar khan Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?