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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
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 8, 2021
Last Updated
December 3, 2021
Sponsor
Bezmialem Vakif University
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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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