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

Osteoarthritis Clinical Trial

— VARABG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04653090
• Other study ID #: 20.0035
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: November 5, 2020
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Osteoarthritis

Intervention

Diagnostic Test:
• Xray
Hip AP Xray

Locations

Country	Name	City	State
France	CHU Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (3)

Khalily C, Lester DK. Results of a tapered cementless femoral stem implanted in varus. J Arthroplasty. 2002 Jun;17(4):463-6. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.	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.	Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.
Secondary	Long-term clinical outcomes with varus or neutral femoral stem.	Clinical status was assessed by the Harris hip score (HHS).	Clinical evaluation was carried out through study completion at an average of 10 years by the surgeon.
Secondary	Long-term radiological outcomes with varus or neutral femoral stem.	Radiological assessment was conducted at the last follow-up in charge antero-posterior and profile X-Ray.	Radiological evaluation was carried out through study completion at an average of 10 years by the surgeon.