Mid-Term Natural Course Postoperative of Crowe Type III-IV Hip Dysplasia
Primary Purpose
Hip Arthropathy, Hip Dysplasia
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Shortened hip arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthropathy
Eligibility Criteria
Inclusion Criteria:
- Crowe type 3 and 4 patients over 18 years of age who had shortened hip replacement surgery
Exclusion Criteria:
- Crowe type 1 or 2 patients over 18 years of age who had shortened hip replacement surgery
- Patients who have previously operated on the contralateral hip
- Patients who underwent shortened hip replacement for a reason other than developmental dysplasia of the hip
Sites / Locations
- Bezmialem Vakıf UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crowe type 3 and 4 patients undergoing shortened hip replacement
Arm Description
Clinical and radiological results of Crowe type 3 and 4 patients who underwent shortened hip prosthesis at 12 and 24 months
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC score range, which indicates the clinical satisfaction of the patients, is between 0-100.
Secondary Outcome Measures
Full Information
NCT ID
NCT05149729
First Posted
October 8, 2021
Last Updated
December 3, 2021
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT05149729
Brief Title
Mid-Term Natural Course Postoperative of Crowe Type III-IV Hip Dysplasia
Official Title
Mid-Term Natural Course of Lower Extremity and Spine After Total Hip Arthroplasty in Patients With Crowe Type III-IV Hip Dysplasia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of preoperative and postoperative mid-term course of patients with Crowe Type 3 and Type 4 hip dysplasia.
Detailed Description
Crowe type 3 and type 4 patients who underwent shortened hip replacement surgery will be followed up for 2 years.
Patients will be called for routine outpatient controls at the 2nd week, 6th week, 3rd month, 6th month, 12th month, 24th month.
Patients will be referred to the physical therapy specialist for abduction strengthening and pelvis tilt corrective exercises starting from the 6th week.
Scoliosis and orthoroentgenography x-rays will be taken at the last control of the patients.
HHS, WOMAC hip score and SF-12 score will be obtained from the patients. Scores, lower extremity and spine angles will be evaluated after the last examinations performed at 12 and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy, Hip Dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients over the age of 18 who underwent Crowe Type 3 and Type 4 shortened hip prosthesis
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Crowe type 3 and 4 patients undergoing shortened hip replacement
Arm Type
Experimental
Arm Description
Clinical and radiological results of Crowe type 3 and 4 patients who underwent shortened hip prosthesis at 12 and 24 months
Intervention Type
Procedure
Intervention Name(s)
Shortened hip arthroplasty
Intervention Description
Crowe type 3 and 4 patients who underwent shortened hip prosthesis
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
The WOMAC score range, which indicates the clinical satisfaction of the patients, is between 0-100.
Time Frame
The degree of improvement in Vomac score will be evaluated by looking at preoperative and postoperative 12th month Vomac scores.( 0-12th month )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Crowe type 3 and 4 patients over 18 years of age who had shortened hip replacement surgery
Exclusion Criteria:
Crowe type 1 or 2 patients over 18 years of age who had shortened hip replacement surgery
Patients who have previously operated on the contralateral hip
Patients who underwent shortened hip replacement for a reason other than developmental dysplasia of the hip
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hakan batuhan kaya
Phone
00905542294339
Email
hbatuhan-kaya-123@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gökçer Uzer
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakıf University
City
İstanbul
State/Province
Fatih
ZIP/Postal Code
34500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Batuhan Kaya
Phone
00905542294339
Email
hbatuhan-kaya-123@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hakan Batuhan Kaya
First Name & Middle Initial & Last Name & Degree
Murat Sarıkaş
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://DOI.ORG/10.1016/J.ARTH.2019.04.028
Description
EFFECTS OF TOTAL HIP ARTHROPLASTY ON AXIAL ALIGNMENT
URL
https://DOI.ORG/10.1016/J.ARTH.2017.05.044
Description
CHANGES IN HIP, KNEE, AND ANKLE CORONAL ALIGNMENTS AFTER TOTAL HIP ARTHROPLASTY WITH TRANSVERSE FEMORAL SHORTENING OSTEOTOMY FOR UNILATERAL CROWE TYPE IV DEVELOPMENTAL DYSPLASIA OF THE HIP
Learn more about this trial
Mid-Term Natural Course Postoperative of Crowe Type III-IV Hip Dysplasia
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