Clinical trial NCT02664272: Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position
Official title: Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in this multicenter clinical observation had at least one of the indications listed below and met all of the inclusion criteria. Patients who met any of the exclusion criteria were not eligible for this study.

Indications:

* Advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis
* Fracture or avascular necrosis of the femoral head
* Follow-on conditions after previous surgery such as osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement.

Brief summary: A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.

Detailed description: The study objective was to evaluate if there was a difference between the femoral position of the last trial rasp and the final implant position of the SL-PLUS™ MIA Ti/HA femoral hip stem. The femoral position of rasp or stem was considered as the height of the implant / rasp in cranio-caudal direction.

Eligibility criteria: Inclusion Criteria:

Patient:

* requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem
* is at least 21 years of age at the time of surgery
* is skeletally mature in the PI's judgment
* has consented to participate in the study by signing the EC approved ICF

Exclusion Criteria:

Patient:

* requires the use of a ceramic-on-ceramic bearing
* has infections, acute or chronic, local or systemic
* has severe muscle, nerve or vascular diseases that endanger the respective limb
* has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis
* has any concomitant disease that may jeopardize implant function
* has a known allergy to study device or one or more of its components
* requires a revision surgery and has extensive bone defects
* has diagnosis of an immunosuppressive disorder
* is pregnant

Primary outcomes:
measure: Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement
timeFrame: Intraoperative examination only
Secondary outcomes:
measure: Number of Hips With Leg Length Discrepancy
timeFrame: Preoperative, directly postoperative (approximately 3 months)
measure: Number of Hips With Intraoperative Complications
timeFrame: Intraoperative examination only
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Universitätsklinik für Orthopädie, PMU Salzburg
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Centrum für Muskuloskeletale Chirurgie Klinik für Orthopädie
city: Munich
country: Germany
facility: Orthopädische Chirurgie München
Study officials:
affiliation: Smith & Nephew Orthopaedics AG
name: Andy Weymann, MD, MBA
role: STUDY_DIRECTOR
References: