Clinical Observation Study With the SBG Stem

Smith & Nephew

Status: Completed

Conditions: Arthroplasty, Hip Replacement

Treatments: Device: SBG hip stem

Study type: Observational

Funder types: Industry

Identifiers

NCT02338661

D8319

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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