Mid-Term Natural Course Postoperative of Crowe Type III-IV Hip Dysplasia

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05149729
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Comparison of preoperative and postoperative mid-term course of patients with Crowe Type 3 and Type 4 hip dysplasia.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthropathy; Hip Dysplasia	Procedure: Shortened hip arthroplasty	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients over the age of 18 who underwent Crowe Type 3 and Type 4 shortened hip prosthesisPatients over the age of 18 who underwent Crowe Type 3 and Type 4 shortened hip prosthesis
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mid-Term Natural Course of Lower Extremity and Spine After Total Hip Arthroplasty in Patients With Crowe Type III-IV Hip Dysplasia
• Actual Study Start Date: Feb 10, 2021
• Anticipated Primary Completion Date: May 10, 2024
• Anticipated Study Completion Date: Jun 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crowe type 3 and 4 patients undergoing shortened hip replacement Clinical and radiological results of Crowe type 3 and 4 patients who underwent shortened hip prosthesis at 12 and 24 months	Procedure: Shortened hip arthroplasty; Crowe type 3 and 4 patients who underwent shortened hip prosthesis

Outcome Measures

Primary Outcome Measures

1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [The degree of improvement in Vomac score will be evaluated by looking at preoperative and postoperative 12th month Vomac scores.( 0-12th month )]

   The WOMAC score range, which indicates the clinical satisfaction of the patients, is between 0-100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakıf University	İstanbul	Fatih	Turkey	34500

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

• Study Director: Gökçer Uzer, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• EFFECTS OF TOTAL HIP ARTHROPLASTY ON AXIAL ALIGNMENT
• 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

Publications

None provided.

• Responsible Party: Murat Sarikas, Orthopaedic surgeon, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT05149729
• Other Study ID Numbers: E.16313
• First Posted: Dec 8, 2021
• Last Update Posted: Dec 8, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital

Study Results

No Results Posted as of Dec 8, 2021