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CompletedNCT02338661Updated May 1, 2018

Clinical Observation Study With the SBG Stem

An observational study in Arthroplasty, Hip Replacement, sponsored by Smith & Nephew Orthopaedics AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-01.

Sponsored by Smith & Nephew Orthopaedics AG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
148
Ages
18 Years and older
Sex
All
01

Study summary

This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.

02

Conditions studied

  • Arthroplasty, Hip Replacement
03

In context

Lead sponsor

Smith & Nephew Orthopaedics AG is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Inclusion criteria

  • patients requiring the implantation of the SBG hip stem

Exclusion criteria

Exclusion Criteria:

  • general medical contraindications to surgery
  • acute or recent infection of joint
  • atrophy or deformation of upper femur
  • muscular atrophy or neuromuscular disease
  • pathologic fractures
  • per- and subtrochanteric fractures
  • revision of failed hip endoprosthesis
  • hypersensitivity to used materials
  • any conditions preventing stable anchoring of the hip prosthesis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
148 participants (actual)
Patient registry
No

Interventions

  • DeviceSBG hip stem
06

What researchers measure

Primary outcomes

  1. Harris Hip Score

    Change in Harris Hip Score from Baseline to 10 years post surgery. The Harris Hip Score scales from 0-100 with higher values representing a better score.

    Time frame: Baseline and 10 years post surgery

Secondary outcomes

  1. Assessment of position of hip stem

    Change in hip stem position from Baseline to 10 years post surgery.

    Time frame: Baseline and 10 years post surgery

  2. Radiographic Analysis: classification of osseointegration of hip stem

    Time frame: 10 years post surgery

  3. Radiographic Analysis: radiolucent lines around hip stem

    Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm.

    Time frame: 10 years post surgery

  4. Radiographic Analysis: number of participants with femoral osteolysis around hip stem

    Time frame: 10 years post surgery

  5. Radiographic Analysis: bone atrophy around hip stem

    Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm.

    Time frame: 10 years post surgery

  6. Radiographic Analysis: bone hypertrophy around hip stem

    Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm.

    Time frame: 10 years post surgery

07

Study locations

1 site
  • Praxis Klinik Gut Buchs
    Buchs, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02338661
Lead sponsor
Smith & Nephew Orthopaedics AG
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
Jan 2004
Primary completion
Apr 24, 2018
Completion
Apr 24, 2018
Last update
May 1, 2018

Study contacts

Beat Schmid, Dr. med.
principal investigator · Praxis Klinik Gut Buchs
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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