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

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Orthopädie, PMU Salzburg, Salzburg, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

Primary outcomes

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

Time frame: Intraoperative examination only

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.

Secondary outcomes

Number of Hips With Leg Length Discrepancy

Time frame: Preoperative, directly postoperative (approximately 3 months)

Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem.
Number of Hips With Intraoperative Complications

Time frame: Intraoperative examination only

Intraoperative complications were collected as a secondary outcome.

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 27, 2016
Registry last updated: Jul 15, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed