Clinical Observation Study With the SBG Stem

Completed

• Conditions: Arthroplasty, Hip Replacement

• Registration Number: NCT02338661
• Lead Sponsor: Smith & Nephew Orthopaedics AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-14
• Status Verified: 2018-04
• Primary Completion: 2018-04-24
• Study Completion: 2018-04-24
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: 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.
Radiographic Analysis: number of participants with femoral osteolysis around hip stem	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.

Trial Locations

Locations (1)

Praxis Klinik Gut Buchs; 🇨🇭 Buchs, Switzerland