Clinical Observation Study With the SBG Stem

Arthroplasty, Hip Replacement Clinical Trial

Official title:

Clinical Observation Study With the SBG Stem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338661
• Other study ID #: D8319
• Status: Completed
• Start date: January 2004
• Est. completion date: April 24, 2018

Study information

• Verified date: April 2018
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Hip Replacement

Intervention

Device:
• SBG hip stem

Locations

Country	Name	City	State
Switzerland	Praxis Klinik Gut Buchs	Buchs

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

Switzerland, 

Outcome

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