Arthroplasty, Hip Replacement Clinical Trial
Official title:
Clinical Observation Study With the SBG Stem
NCT number | NCT02338661 |
Other study ID # | D8319 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2004 |
Est. completion date | April 24, 2018 |
Verified date | April 2018 |
Source | Smith & Nephew, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Praxis Klinik Gut Buchs | Buchs |
Lead Sponsor | Collaborator |
---|---|
Smith & Nephew Orthopaedics AG |
Switzerland,
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 |
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