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Completed

NCT Number: NCT02338661

Clinical Observation Study With the SBG Stem

This study is a prospective, single-center, postmarket clinical observation to observe the clinical and radiographic long-term performance of the SBG hip stem.

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Key information

Conditions

Arthroplasty, Hip Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Praxis Klinik Gut Buchs

Buchs, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SBG hip stem

Device

Primary outcomes

  1. Harris Hip Score

    Time frame: Baseline and 10 years post surgery

    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.

Secondary outcomes

  1. Assessment of position of hip stem

    Time frame: Baseline and 10 years post surgery

    Change in hip stem position from Baseline to 10 years post surgery.

  2. Radiographic Analysis: classification of osseointegration of hip stem

    Time frame: 10 years post surgery

  3. Radiographic Analysis: radiolucent lines around hip stem

    Time frame: 10 years post surgery

    Radiographic measurements will be taken of linear radiolucencies. Radiolucent lines will be measured in mm.

  4. Radiographic Analysis: number of participants with femoral osteolysis around hip stem

    Time frame: 10 years post surgery

  5. Radiographic Analysis: bone atrophy around hip stem

    Time frame: 10 years post surgery

    Radiographic measurements will be taken of bone atrophy. Bone atrophy will be measured in mm.

  6. Radiographic Analysis: bone hypertrophy around hip stem

    Time frame: 10 years post surgery

    Radiographic measurements will be taken of bone hypertrophy. Bone hypertrophy will be measured in mm.

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Important dates

Study start
2004
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2015
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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