Protocol summary

Summary
The aim of this study was to compare short-stem with standard-stem prosthesis outcomes in total hip arthroplasty. This study was performed as a randomized clinical trial. 84 patients were selected among cases referred to Sina University Hospital, Tehran, Iran between April 2010 and April2012 with severe hip osteodegeneration. Total hip arthroplasty were performed with short-stem or standard-stem prostheses after obtaining written informed consent from patients. Balanced Block Randomization method was used to do a random allocation. Clinical outcomes were evaluated based on Harris Hip Score (HHS). Patients were followed up for at least one year. All patients were examined at 2 weeks, 6 weeks, 3 months, 6 months and one year after surgery. In each visit, Control X-Ray was obtained and bone and prosthetic position were assessed. Also, the symptoms such as infection, pain, claudication, ability to climb stairs, using crutches and weight bearing were rechecked.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022611560N4
Registration date: 2013-03-27, 1392/01/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-27, 1392/01/07
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical outcome comparison between short-stem and standard-stem prosthesis of total hip arthroplasty
Public title
Total hip displacment with two difference prostesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: underlying disease such as non-inflammatory degenerative disease of hip; Osteoartheritis; Avascular necrosis of hip; skeletal system maturity; good condition; no history of surgery; no congenital dysplasia of hip; no bone metabolic disease; no Osteoprosis; no history of bone infection; no history of prostesis sensitivity; no pregnancy. Exclusion criteria: not follow up, post-surgery infection; preprostetics fracture during or after surgery; patient death.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, office center, Keshavarz Blvd.
City
Tehran
Postal code
1169452874
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
13521651د90

Health conditions studied

1

Description of health condition studied
Total Hip Arthroplasty
ICD-10 code
Z96.6
ICD-10 code description
Hip-joint replacement (partial)(total)

Primary outcomes

1

Description
The improvment of joint function
Timepoint
pre-operation, 2th week, 6th week,3th month, 6th month, 12th month
Method of measurement
Harris Hip Score

Secondary outcomes

1

Description
Bleeding peri operation
Timepoint
during operation
Method of measurement
volume (cc)

Intervention groups

1

Description
Total hip arthroplasty (short-stem prostheses)
Category
Treatment - Surgery

2

Description
Total Hip Arthroplasty (standard-stem prostheses)
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mojgan Seifi
Street address
Sina Hospital, Hasan Abad Sq, Imam khomeni Ave
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research, Teharn University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Center Office, Teharn University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Teharn 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
Sina Traume and Surgery Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr.Tayeb Ramim
Position
General Practitioner
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq, Imam Khomeini Ave
City
Tehran
Postal code
1163754849
Phone
+98 21 6642 5312
Fax
Email
tayebramim@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical school, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojgan Seifi
Position
Orthpedics Assisstant
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq. Imam khomeini Ave
City
Tehran
Postal code
1114512452
Phone
+98 21 6634 8502
Fax
Email
seifi_mozhgan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical school, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojgan Seifi
Position
Orthpedics Assisstant
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq. Imam khomeini Ave
City
Tehran
Postal code
1124512415
Phone
+98 21 6634 8502
Fax
Email
seifi_mozhgan@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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