Out comes of acetabular labrum excision in pain and functional scores of patients undergoing bipolar-hemiarthroplasty
Design
Two parallel group non-randomized trial with blinded participants, postoperative care and outcome assessment, evaluating postoperative outcomes in bipolar-hemiarthroplasty
Settings and conduct
Conducted in an orthopedic hospital between 2020 and 2021, we wiil perform a new technique of bipolar-hemiarthroplasty (with labrum sxicsion) since the predicted time for IRCT approve. Control group consists of patients who had bipolar-hemiarthroplasty in conventional technique before the start of study. All patients will be informed about the operation excepts the details of technique (labrum excision).
Participants/Inclusion and exclusion criteria
Patients with femoral neck fracture, undergoing bipolar-hemiarthroplasty
Intervention groups
Intervention consists of acetabular labrum excision in patients undergoing bipolar-hemiarthroplasty, while in control group hemiarthroplasty will be done conventionally.
Main outcome variables
1-VAS score: quantitative variable for pain assessment raging form 0-100
2-Harris Hip Score (HSS) questionnaire: has a maximum of 100 points (best possible outcome) covering pain (1 item, 0–44 points), function (7 items, 0–47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200521047525N1
Registration date:2020-05-26, 1399/03/06
Registration timing:prospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Mohammad Movahedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8215
Email address
m.movahedinia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The short-term out comes of acetabular labrum excision in pain and functional scores of patients undergoing bipolar-hemiarthroplasty
Public title
Labrum excision in bipolar-hemiarthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with femoral neck fracture, undergoing bipolar-hemiarthroplasty
Exclusion criteria:
severe medical commodities in non-displaced freactures
life expectancy < 6 weeks
non-displaced fractures in painless patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants included in the study will be informed about the advantageous and complications of the operation. Written informed consent will be obtained from all patients before initiation of the study. But, patients will be blinded about details of surgery techniques (excision or preservation of labrum). This blindness will also be applied for health care providers (including nurses but not the corresponding doctor-surgeon-), data collector (another doctor-not surgeon-), outcome assessor, and draft writer. the corresponding doctor (surgeon) and operating room staffs will be alert about the technique inevitably.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
Shahid Beheshti University of Medical Sciences, Next to Ayatollah Taleghani Hospital, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.MSP.REC.1398.1016
Health conditions studied
1
Description of health condition studied
Fracture of neck of femur in osteoporosis
ICD-10 code
S72.0
ICD-10 code description
Fracture of neck of femur
2
Description of health condition studied
osteoporosis
ICD-10 code
M80.9
ICD-10 code description
Unspecified osteoporosis with pathological fracture
Primary outcomes
1
Description
VAS score: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between “no pain” and “worst pain.”
Timepoint
Primary outcome will be measured in 3, 6 and 12 months following the surgery.
Method of measurement
The visual analog scale (VAS)
2
Description
Function assessment by HSS questionnaire: has a maximum of 100 points (best possible outcome) covering pain (1 item, 0–44 points), function (7 items, 0–47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Timepoint
Primary outcome will be measured in 3, 6 and 12 months following the surgery.
Method of measurement
HSS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patient of this group will undergo bipolar-hemiarthroplasty with a new technique of acetabular labrum excision.
Category
Treatment - Surgery
2
Description
Control group: Patient of this group will undergo bipolar-hemiarthroplasty with conventional technique (preserving the acetabular labrum).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Mohammad Movahedinia
Street address
Unit1, Floor1, No16, Alley Yousef, St Mirkhani, Sq Tohid
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Movahedinia
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Sharifimanesh st.
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Fax
Email
m.movahedinia@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Movahedinia
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Sharifimanesh st.
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Fax
Email
m.movahedinia@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Movahedinia
Position
Orthopaedic resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Sharifimanesh st.
City
Tehran
Province
Tehran
Postal code
1419763594
Phone
+98 21 6694 8215
Fax
Email
m.movahedinia@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is a plan to make clinical study reports and data of this study available to other researchers (typically after the end of the study). These data consist of all variables (except patient's identification) for half of each group participants (control/intervention) provided in SPSS format.
When the data will become available and for how long
The start date of data availability will be in March 2022.
To whom data/document is available
Documents will be shared and available for researchers working in any academic institutions.
Under which criteria data/document could be used
Any requests to access all documents (for example for a systematic review) should be sent to responsible researcher.
From where data/document is obtainable
To contact the corresponding researcher:
Email: mmvn93@gmail.com
WhatsApp: 00989216361088
Linkedin: mohammad movahedinia
What processes are involved for a request to access data/document
After contacting the corresponding researcher, documents will be sent in one month.