Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2018
Source Smith & Nephew, Inc.
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03393819 - Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery N/A
Completed NCT02580214 - Immunonutrition in Total Hip Arthroplasty Phase 2/Phase 3
Completed NCT02839876 - Intravenous Versus Oral Acetaminophen in Primary Total Hip Arthroplasty Phase 4
Recruiting NCT06107296 - Early Perioperative Quality Of Recovery After Hip and Knee Arthroplasty: a Retrospective Comparative Cohort Study
Recruiting NCT03806114 - Dislocation Precautions N/A
Completed NCT02342236 - Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty N/A
Completed NCT01514006 - Postoperative Anemia and Functional Outcomes After Fast-track Primary Hip Arthroplasty N/A