How Spinopelvic Movements Affect Hip Function After Total Hip Arthroplasty

NCT ID: NCT06711042

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-02-01

Brief Summary

Our study aims to evaluate the effect of spinopelvic movement on hip functions in individuals who have undergone total hip arthroplasty (THA). This study will contribute to the literature by helping identify and prevent issues experienced by THA patients, ranging from hip pain to limited mobility and even hip dislocation.

Detailed Description

Total hip arthroplasty (THA) is a widely accepted surgical procedure that effectively alleviates pain, enhances mobility, and improves physical function in patients with hip osteoarthritis. However, improper placement of implants during surgery can lead to complications such as abnormal edge loading, early wear of polyethylene components, ceramic insert fractures, or hip dislocations, often requiring early revision surgeries. While Lewinnek's "safe zone" (30°-50° inclination and 5°-25° anteversion for the acetabular component) has traditionally been used as a guideline, recent studies have reported significant dislocation rates even within these parameters, highlighting spinopelvic movement abnormalities as a critical factor. Normal spinopelvic-hip mechanics allow for adaptive changes in the pelvis and acetabulum during positional transitions, thereby preventing anterior or posterior impingement in the hip joint. However, patients with restricted lumbosacral mobility are at a greater risk of impingement-related symptoms. To address these challenges, advanced metrics such as sacral slope difference (ΔSS), pelvic-femoral angle (PFA), and combined sagittal index (CSI) have been introduced to better define functional safe zones and assess risks of hip impingement and dislocation. While the relationship between CSI and hip dislocations is established, its impact on hip function remains unclear. This study aims to evaluate the effect of spinopelvic movement on hip function in individuals who have undergone THA. By identifying and preventing complications such as hip pain, mobility restrictions, and dislocations, the research seeks to provide meaningful contributions to the literature and improve patient outcomes.

Conditions

Total Hip Replacement; Hip Dislocation; Hip Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group (Implant Placement Within Functional Safe Zone - FSZ)

This group will consist of patients who have previously undergone total hip arthroplasty (TKA) with implant placement within the functional safe zone (FSZ).

functional tests and radiographic analysis

Intervention Type: DIAGNOSTIC_TEST

In this observational study, no active interventions or treatments will be administered to the participants. Both groups (Control Group and Experimental Group) will undergo clinical evaluations, including functional tests (WOMAC, Harris Hip Score, Oxford Hip Score, SF-12, TUG) and radiographic analysis (angular measurements). The participants' outcomes will be compared based on their implant placement (within or outside the Functional Safe Zone).

Experimental Group (Implant Placement Outside Functional Safe Zone - FSZ)

This group will consist of patients who have previously undergone total hip arthroplasty (TKA) but have implant placement outside the functional safe zone (FSZ).

functional tests and radiographic analysis

Intervention Type: DIAGNOSTIC_TEST

In this observational study, no active interventions or treatments will be administered to the participants. Both groups (Control Group and Experimental Group) will undergo clinical evaluations, including functional tests (WOMAC, Harris Hip Score, Oxford Hip Score, SF-12, TUG) and radiographic analysis (angular measurements). The participants' outcomes will be compared based on their implant placement (within or outside the Functional Safe Zone).

Interventions

functional tests and radiographic analysis

In this observational study, no active interventions or treatments will be administered to the participants. Both groups (Control Group and Experimental Group) will undergo clinical evaluations, including functional tests (WOMAC, Harris Hip Score, Oxford Hip Score, SF-12, TUG) and radiographic analysis (angular measurements). The participants' outcomes will be compared based on their implant placement (within or outside the Functional Safe Zone).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients aged 60 and older.
• At least 12 months post-surgery.

Exclusion Criteria

• Patients with modular neck implants, metal-metal, or ceramic bearing surfaces.
• Patients with hip infection or advanced osteoarthritis in the contralateral hip.
• Patients with leg length discrepancy.
• Patients with neurological, orthopedic, or systemic diseases affecting gait or balance.
• Patients with a body mass index (BMI) greater than 40 kg/m².

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ordu University

OTHER

Sponsor Role: lead

Responsible Party

Elif AYGUN POLAT

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yusuf POLAT, Assoc.Prof.

Role: STUDY_DIRECTOR

Ordu University

Elif AYGUN POLAT, PhD

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Murat ALPARSLAN, MD

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Tolga KECECİ, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Alper ÇIRAKLI, Prof.

Role: STUDY_CHAIR

Ordu University

Locations

Ordu University

Ordu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ODU-SBFTR-AYGUNPOLAT-004

Identifier Type: -

Identifier Source: org_study_id