Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

Osteoarthritis Clinical Trial

Official title:

Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664272
• Other study ID #: SL MIA rasp 15-4567-03
• Status: Completed
• Start date: April 6, 2016
• Est. completion date: June 7, 2017

Study information

• Verified date: May 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 7, 2017
• Est. primary completion date: June 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Total Hip Arthroplasty

Locations

Country	Name	City	State
Austria	Universitätsklinik für Orthopädie, PMU Salzburg	Salzburg
Germany	Charité Universitätsmedizin Berlin Centrum für Muskuloskeletale Chirurgie Klinik für Orthopädie	Berlin
Germany	Orthopädische Chirurgie München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used.; The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter.	Intraoperative examination only
Secondary	Number of Hips With Leg Length Discrepancy	Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem.	Preoperative, directly postoperative (approximately 3 months)
Secondary	Number of Hips With Intraoperative Complications	Intraoperative complications were collected as a secondary outcome.	Intraoperative examination only