Clinical trial NCT04653090: Varus Stem Positioning of a Cementless Anatomical THA. (VARABG)
Official title: Varus Stem Positioning Does Not Affect Long-term Functional Outcome in Cementless Anatomical Total Hip Arthroplasty.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Arthroplasty Complications
Keywords: Total hip arthroplasty
varus alignment
anatomical stem
survivorship
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators identified all patients who underwent proximal HA-coated anatomic tapered femoral stem primary THAs between October 1998 and July 2008, through our institutional total joint registry. The data were prospectively collected on the Orthowave© database. This included patients who had an uncemented ABG-2 stem (Stryker, Mahwah, NJ). The study was a test-case retrospective analysis and an institutional review board approval was obtained prior to initiation of the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.
timeFrame: Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.
Secondary outcomes:
measure: Long-term clinical outcomes with varus or neutral femoral stem.
timeFrame: Clinical evaluation was carried out through study completion at an average of 10 years by the surgeon.
measure: Long-term radiological outcomes with varus or neutral femoral stem.
timeFrame: Radiological evaluation was carried out through study completion at an average of 10 years by the surgeon.
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nîmes
state: Gard
Study officials:
References:
citation: Reina N, Salib CG, Perry KI, Hanssen AD, Berry DJ, Abdel MP. Mild Coronal Stem Malalignment Does Not Negatively Impact Survivorship or Clinical Results in Uncemented Primary Total Hip Arthroplasties With Dual-Tapered Implants. J Arthroplasty. 2019 Jun;34(6):1127-1131. doi: 10.1016/j.arth.2019.01.055. Epub 2019 Jan 31.
citation: Khalily C, Lester DK. Results of a tapered cementless femoral stem implanted in varus. J Arthroplasty. 2002 Jun;17(4):463-6. doi: 10.1054/arth.2002.32171.
citation: Min BW, Song KS, Bae KC, Cho CH, Kang CH, Kim SY. The effect of stem alignment on results of total hip arthroplasty with a cementless tapered-wedge femoral component. J Arthroplasty. 2008 Apr;23(3):418-23. doi: 10.1016/j.arth.2007.04.002. Epub 2007 Nov 9.