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IRCT20200521047525N1 IRCT 2020-05-26 Shahid Beheshti University of Medical Sciences Labrum excision in bipolar-hemiarthroplasty The short-term out comes of acetabular labrum excision in pain and functional scores of patients undergoing bipolar-hemiarthroplasty 2020-08-22 anticipated 50 Complete https://irct.ir/trial/48367 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Condition 1: Fracture of neck of femur in osteoporosis. Condition 2: osteoporosis. Intervention 1: Intervention group: Patient of this group will undergo bipolar-hemiarthroplasty with a new technique of acetabular labrum excision. Intervention 2: Control group: Patient of this group will undergo bipolar-hemiarthroplasty with conventional technique (preserving the acetabular labrum). Yes - There is a plan to make this available What will be shared: 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 start date of data availability will be in March 2022. To whom: Documents will be shared and available for researchers working in any academic institutions. Conditions: Any requests to access all documents (for example for a systematic review) should be sent to responsible researcher. Where to obtain: To contact the corresponding researcher: Email: mmvn93@gmail.com WhatsApp: 00989216361088 Linkedin: mohammad movahedinia How to obtain: After contacting the corresponding researcher, documents will be sent in one month. Comments:
public Mohammad Movahedinia
Sharifimanesh st.
Tehran Iran (Islamic Republic of) 1419763594 +98 21 6694 8215 m.movahedinia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Movahedinia
Sharifimanesh st.
Tehran Iran (Islamic Republic of) 1419763594 +98 21 6694 8215 m.movahedinia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with femoral neck fracture, undergoing bipolar-hemiarthroplasty no limit no limit Both severe medical commodities in non-displaced freactures life expectancy < 6 weeks non-displaced fractures in painless patients S72.0 M80.9 Fracture of neck of femur Unspecified osteoporosis with pathological fracture Treatment - Surgery Treatment - Surgery Intervention group: Patient of this group will undergo bipolar-hemiarthroplasty with a new technique of acetabular labrum excision. Control group: Patient of this group will undergo bipolar-hemiarthroplasty with conventional technique (preserving the acetabular labrum). 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). 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. Shahid Beheshti University of Medical Sciences Approved 2020-03-10 Shahid Beheshti University of Medical Sciences Ethics Committee Shahid Beheshti University of Medical Sciences, Next to Ayatollah Taleghani Hospital, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)