NCT02338661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
11 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

14.3 years

First QC Date

December 12, 2014

Last Update Submit

April 30, 2018

Conditions

Arthroplasty, Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Assessment of position of hip stem

    Baseline and 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 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

  • +1 more secondary outcomes

Interventions

SBG hip stemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • patients requiring the implantation of the SBG hip stem

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Praxis Klinik Gut Buchs

Buchs, Switzerland

Location

Study Officials

  • Beat Schmid, Dr. med.

    Praxis Klinik Gut Buchs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

January 14, 2015

Study Start

January 1, 2004

Primary Completion

April 24, 2018

Study Completion

April 24, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

CH(1)