Varus Stem Positioning of a Cementless Anatomical THA. (VARABG)

Completed

• Conditions: Osteoarthritis; Arthroplasty Complications
• Interventions: Diagnostic Test: Xray

• Registration Number: NCT04653090
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Varus positioning is the most common femoral malposition in total hip arthroplasty (THA). The aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment.

Detailed Description

Data were prospectively collected and retrospectively reviewed for all patients who received a cementless anatomical femoral stem in THA between 1998 and 2008. After exclusion criteria applied, 127 stems had an varus axis deviated by more than 3 degrees (varus group) and 156 had an alignment between 0 and 2.9° from the femoral axis (neutral group). Survivorship rates, complications, clinical scores, thigh pain, radiological score, cortical hypertrophy and filling rate were analyzed. Mean follow-up was 10 years.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-05-01
• Status Verified: 2020-11
• Study Completion: 2020-11-05
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

• All patients received by several senior surgeons, the same standardized posterolateral total hip arthroplasty, and the same rehabilitation protocol.

Exclusion Criteria

• Etiologies other than osteoarthritis (osteonecrosis, fracture, dysplasia, rheumatoïd arthritis),
• Complex cases with additional procedure,
• Dual-taper modular or cemented stem,
• Incomplete preoperative data or less than one-year postoperative data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Varus group	Xray	Radiographic stem axis was assessed on standard anteroposterior hip radiographs performed at the 3-month follow-up visit. Alignment was evaluated as described by Reina et al., by the angular deviation of the anatomic femoral axis and the stem axis. The 3 degrees minimal-value was considered to be the threshold defining a varus stem.
Neutral group	Xray	Alignment between anatomic femoral axis ans stem axis was less than 3°.

Primary Outcome Measures

Name	Time	Method
Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.	Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.	Kaplan-Meier survivorships free of revision of the femoral component for any reason, femoral fracture and revision of femoral component for fracture were calculated and compared by log-rank test for both group.

Secondary Outcome Measures

Name	Time	Method
Long-term clinical outcomes with varus or neutral femoral stem.	Clinical evaluation was carried out through study completion at an average of 10 years by the surgeon.	Clinical status was assessed by the Harris hip score (HHS).
Long-term radiological outcomes with varus or neutral femoral stem.	Radiological evaluation was carried out through study completion at an average of 10 years by the surgeon.	Radiological assessment was conducted at the last follow-up in charge antero-posterior and profile X-Ray.

Trial Locations

Locations (1)

CHU Nîmes; 🇫🇷 Nîmes, Gard, France