NCT04653090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 13, 2020

Last Update Submit

November 26, 2020

Conditions

OsteoarthritisArthroplasty Complications

Keywords

Total hip arthroplastyvarus alignmentanatomical stemsurvivorship

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Varus group

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.

Diagnostic Test: Xray

Neutral group

Alignment between anatomic femoral axis ans stem axis was less than 3°.

Diagnostic Test: Xray

Interventions

XrayDIAGNOSTIC_TEST

Hip AP Xray

Neutral groupVarus group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nîmes

Nîmes, Gard, 30900, France

Location

Related Publications (3)

  • 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.

    PMID: 30773361BACKGROUND

  • 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.

    PMID: 12066277BACKGROUND

  • 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.

    PMID: 18358382BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2020

First Posted

December 4, 2020

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

November 5, 2020

Last Updated

December 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)