Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This single-center prospective comparative study was conducted at the Joint Reconstruction Center of China Medical University Hospital between March 1, 2021 and September 30, 2021. Eligible participants were adults diagnosed with advanced hip osteoarthritis, avascular necrosis, or developmental dysplasia of the hip requiring THA. Exclusion criteria included prior hip joint infection, severe LLD requiring additional reconstructive procedures, significant spinal pathology affecting spinopelvic balance, or radiographs inadequate for measurement.
All procedures were performed via the direct anterior approach (DAA) on a traction table by the principal surgeon. Functional LLD was assessed preoperatively using a block test, with wooden blocks (5 mm increments) placed under the heel until the patient reported equal leg lengths.
Patients in the navigation group underwent THA with an imageless navigation system (Stryker OrthoMap Versatile Hip Navigation) to record intraoperative limb length change and acetabular cup positioning; the conventional group underwent standard THA without navigation.
Primary outcome was the patients' expectation gap (PEG), defined as the difference between preoperative functional LLD and postoperative radiographic limb length change. Secondary outcomes included intraoperative fluoroscopy time, WOMAC scores at baseline, 3 weeks, and 3 months postoperatively, and the proportion of outliers (PEG > 10 mm).
The study was approved by the Research Ethics Committee of China Medical University Hospital (CMUH112-REC1-149). Written informed consent was obtained from all participants, and the study adhered to the Declaration of Helsinki.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeons' Expectation Gap (SEG) | Difference between intraoperative navigation leg length measurement (mm) and postoperative radiographic leg length change (mm). | Intraoperative and 3 months postoperatively |
| Outlier Rate (>10 mm PEG) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chih-Hung Hung, MD | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | 台中市 | 404 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D005271 | Femur Head Necrosis |
| D000082602 | Developmental Dysplasia of the Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000085022 | Surgical Navigation Systems |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional total hip arthroplasty | Procedure | Patients underwent total hip arthroplasty via the direct anterior approach conventionally. |
|
Percentage of patients with Patients' Expectation Gap greater than 10 mm.
| 3 months postoperatively |
| WOMAC Pain Score Change | Change in WOMAC pain subscale score (0-20, lower scores indicate less pain) from baseline. | Baseline, 3 weeks postoperatively, 3 months postoperatively |
| WOMAC Stiffness Score Change | Change in WOMAC stiffness subscale score (0-8, lower scores indicate less stiffness) from baseline. | Baseline, 3 weeks postoperatively, 3 months postoperatively |
| WOMAC Function Score Change | Change in WOMAC function subscale score (0-68, lower scores indicate better function) from baseline. | Baseline, 3 weeks postoperatively, 3 months postoperatively |
| Fluoroscopy Execution Time | Duration of intraoperative fluoroscopy use (seconds). | Intraoperative |
| Operative Time | Duration of total surgical procedure (minutes). | Intraoperative |
| Blood Loss | Total intraoperative blood loss (milliliters). | Intraoperative |
| Length Change | Difference in radiographic leg length pre- and postoperatively (mm). | Baseline and 3 months postoperatively |
| D012216 |
| Rheumatic Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006617 | Hip Dislocation |
| D004204 | Joint Dislocations |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |