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Completed

NCT Number: NCT04653090

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Arthroplasty Complications Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nîmes

Nîmes, Gard, 30900, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xray

Diagnostic Test

Hip AP Xray

Primary outcomes

  1. Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.

    Time frame: 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 outcomes

  1. Long-term clinical outcomes with varus or neutral femoral stem.

    Time frame: 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).

  2. Long-term radiological outcomes with varus or neutral femoral stem.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Varus Stem Positioning Does Not Affect Long-term Functional Outcome in Cementless Anatomical Total Hip Arthroplasty.

Acronym: VARABG

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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