Clinical Observation Study With the SBG Stem

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02338661

Enrollment

148

Registered

2015-01-14

Start date

2004-01-31

Completion date

2018-04-24

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Hip Replacement

Brief 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.

Interventions

DEVICESBG hip stem

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients requiring the implantation of the SBG hip stem

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

Design outcomes

Primary

Measure	Time frame	Description
Harris Hip Score	Baseline and 10 years post surgery	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.

Secondary

Measure	Time frame	Description
Radiographic Analysis: classification of osseointegration of hip stem	10 years post surgery	—
Radiographic Analysis: radiolucent lines around hip stem	10 years post surgery	Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm.
Assessment of position of hip stem	Baseline and 10 years post surgery	Change in hip stem position from Baseline to 10 years post surgery.
Radiographic Analysis: bone atrophy around hip stem	10 years post surgery	Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm.
Radiographic Analysis: bone hypertrophy around hip stem	10 years post surgery	Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm.
Radiographic Analysis: number of participants with femoral osteolysis around hip stem	10 years post surgery	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026