How Spinopelvic Movements Affect Hip Function After Total Hip Arthroplasty

NCT06711042 | Completed

• 1 other identifier: ODU-SBFTR-AYGUNPOLAT-004
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement; Hip Dislocation; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Radiographic Angular Measurements

  The angular measurements of the implant positions will be assessed using pre-existing routine control radiographs. This includes analysis of the pelvic tilt, acetabular anteversion, and femoral anteversion, which will be measured by two experienced radiologists using the General Electric Centricity PACS system.

  At least 12 months after surgery

• WOMAC (Western Ontario and McMaster Osteoarthritis Index)

  The WOMAC score will be used to assess pain, stiffness, and physical function in patients with hip osteoarthritis. It includes 24 questions across three domains: pain, stiffness, and physical function

  At least 12 months after surgery

• Harris Hip Score (HHS)

  The Harris Hip Score will be used to assess the hip function and pain level in patients who have undergone total hip arthroplasty. It consists of several domains, including pain, function, range of motion, and deformity.

  At least 12 months after surgery

• Oxford Hip Score

  The Oxford Hip Score will be used to assess hip function and the impact of hip arthritis on patients' quality of life. It includes questions on pain and function during daily activities.

  At least 12 months after surgery

• SF-12 (Short Form-12 Health Survey)

  The SF-12 is a 12-item questionnaire used to assess the overall health-related quality of life. It includes physical and mental health components and provides a summary score for each.

  At least 12 months after surgery

• TUG (Timed Up and Go) Test

  The Timed Up and Go (TUG) test is a functional assessment to evaluate mobility, balance, and risk of falls. The patient is asked to rise from a seated position, walk 3 meters, turn around, walk back, and sit down again. The total time taken to complete the task is measured in seconds. It is useful in assessing recovery progress and mobility after total hip arthroplasty (THA).

  At least 12 months after surgery

Study Arms (2)

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).

Diagnostic Test: functional tests and radiographic analysis

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).

Diagnostic Test: functional tests and radiographic analysis

Interventions

functional tests and radiographic analysis 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).

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include patients who underwent primary total hip arthroplasty using the posterolateral approach by the same surgeon at Ordu University Training and Research Hospital, Department of Orthopedics and Traumatology, during the years 2022-2023. Eligible patients must be aged 60 years or older and have a minimum of 12 months post-surgery. Exclusion criteria include patients with modular neck implants, metal-metal, or ceramic bearing surfaces, hip infections, advanced osteoarthritis in the contralateral hip, leg length discrepancy, neurological, orthopedic, or systemic diseases affecting gait or balance, or a body mass index (BMI) greater than 40 kg/m².

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University

Ordu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Dislocation; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Osteoarthritis; Arthritis; Rheumatic Diseases

Study Officials

• Yusuf POLAT, Assoc.Prof.

  Ordu University

  STUDY DIRECTOR

• Elif AYGUN POLAT, PhD

  Ordu University

  PRINCIPAL INVESTIGATOR

• Murat ALPARSLAN, MD

  Ordu University

  PRINCIPAL INVESTIGATOR

• Tolga KECECİ, Assoc.Prof.

  Ordu University

  PRINCIPAL INVESTIGATOR

• Alper ÇIRAKLI, Prof.

  Ordu University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2024
• Primary Completion: January 12, 2025
• Study Completion: February 1, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)