Overview

This trial is active, not recruiting.

Condition arthroplasty, hip replacement
Treatment sbg hip stem
Sponsor Smith & Nephew Orthopaedics AG
Start date January 2004
End date February 2018
Trial size 148 participants
Trial identifier NCT02338661, D8319

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Harris Hip Score
time frame: Baseline and 10 years post surgery

Secondary Outcomes

Measure
Assessment of position of hip stem
time frame: Baseline and 10 years post surgery
Radiographic Analysis: classification of osseointegration of hip stem
time frame: 10 years post surgery
Radiographic Analysis: radiolucent lines around hip stem
time frame: 10 years post surgery
Radiographic Analysis: number of participants with femoral osteolysis around hip stem
time frame: 10 years post surgery
Radiographic Analysis: bone atrophy around hip stem
time frame: 10 years post surgery
Radiographic Analysis: bone hypertrophy around hip stem
time frame: 10 years post surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Observation Study With the SBG Stem
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Smith & Nephew, Inc..