Efficiency and Safety of Navigation Aids in Total Hip Arthroplasty With Direct Anterior Approach

NCT07134036 | Completed DMC FDA Device

• 1 other identifier: CMUH112-REC1-149
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective clinical study aimed to evaluate the effectiveness of an imageless navigation system in total hip arthroplasty (THA) via the direct anterior approach (DAA) on a traction table for reducing functional limb length discrepancy (LLD) compared with conventional techniques. Seventy-two patients with advanced hip osteoarthritis, avascular necrosis, or developmental dysplasia of the hip undergoing THA between March 1, 2021 and September 30, 2021 were included. Functional LLD was assessed using a preoperative block test. Participants were assigned to the navigation or conventional group based on patient preference. Outcomes included operative parameters, intraoperative fluoroscopy time, limb length measurements, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.

Conditions

Osteoarthritis, Hip; Femur Head Necrosis; Developmental Dysplasia of the Hip

Keywords

Direct Anterior Approach; Limb Length Discrepancy; Arthroplasty, Replacement, Hip; Surgery, Computer-Assisted; Surgical Navigation Systems

Outcome Measures

Primary Outcomes (1)

• Patients' Expectation Gap (PEG)

  Difference between preoperative functional leg length discrepancy (measured with block test, mm) and postoperative radiographic leg length change (mm).

  Baseline (preoperative) and 3 months postoperatively

Secondary Outcomes (9)

• Surgeons' Expectation Gap (SEG)

  Intraoperative and 3 months postoperatively

• Outlier Rate (>10 mm PEG)

  3 months postoperatively

• WOMAC Pain Score Change

  Baseline, 3 weeks postoperatively, 3 months postoperatively

• WOMAC Stiffness Score Change

  Baseline, 3 weeks postoperatively, 3 months postoperatively

• WOMAC Function Score Change

  Baseline, 3 weeks postoperatively, 3 months postoperatively

Study Arms (2)

Conventional THA

ACTIVE COMPARATOR

Participants in this group underwent total hip arthroplasty (THA) via the direct anterior approach on a traction table without the use of a computer navigation system. This arm represents the conventional surgical technique routinely performed at our institution, where intraoperative limb length assessment was based on standard fluoroscopic guidance and anatomical landmarks.

Procedure: Conventional total hip arthroplasty

Navigation-assisted THA

EXPERIMENTAL

Participants in this group underwent total hip arthroplasty (THA) via the direct anterior approach on a traction table with the assistance of an imageless computer navigation system (Stryker OrthoMap Versatile Hip Navigation). The navigation system provided real-time intraoperative feedback on limb length change and acetabular cup positioning, aiming to improve accuracy and reduce reliance on fluoroscopy.

Device: Navigation system

Interventions

Navigation system DEVICE

Patients underwent total hip arthroplasty via the direct anterior approach using a computer navigation system to assist in intraoperative limb length measurement.

Navigation-assisted THA

Conventional total hip arthroplasty PROCEDURE

Patients underwent total hip arthroplasty via the direct anterior approach conventionally.

Conventional THA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of advanced hip osteoarthritis (OA) warranting total hip arthroplasty (THA)
• Clinical diagnosis of avascular necrosis (AVN) of the femoral head warranting total hip arthroplasty (THA)
• Clinical diagnosis of developmental dysplasia of the hip (DDH) warranting total hip arthroplasty (THA)

You may not qualify if:

• Documented history of prior hip joint infection
• Severe limb length discrepancy requiring supplementary surgical interventions
• Significant spinal pathology affecting spinopelvic balance
• Radiographs in which the lesser trochanters and teardrops cannot be clearly defined

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 台中市, 404, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis; Developmental Dysplasia of the Hip

Interventions

Surgical Navigation Systems

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hip Dislocation; Joint Dislocations; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Chih-Hung Hung, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: August 21, 2025
• Study Start: March 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)