Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft

Primary Total Hip Arthroplasty Clinical Trial

— SL-Plus HA MIA  

Official title:

Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04036071
• Other study ID #: D10080-2
• Status: Terminated
• Start date: May 15, 2009
• Est. completion date: October 27, 2020

Study information

• Verified date: May 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS

™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. Intervention (if applicable): Implantation of a total hip endoprosthesis Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration. Clinical: Harris Hip Score, HOOS Score, EQ-5D, implant-related complications, revisions Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct benefit for the patients from the participation in the study is currently not yet foreseeable.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: October 27, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Primary total hip endoprosthesis of the side affected (unilateral or bilateral)

• Patient shall be provided with a HA coated SLPLUS™ MIA stem

• Patient has no general medical contraindications regarding the surgery

• Signed informed consent form for the participation in the study

• X-ray examinations are possible

• Patient is willing to participate in the post-operative follow-up program

• Age: 18-75 years

Exclusion Criteria:

• Previous failed hip joint surgery (endoprosthesis) of the side affected

• Previous infections in the joint affected; systemic infections

Related Conditions & MeSH terms

• Primary Total Hip Arthroplasty

Intervention

Device:
• Total Hip Arthroplasty
Total Hip Arthroplasty using the SL-PLUS™ MIA cement free hip stem

Locations

Country	Name	City	State
Austria	Orthopädische Landesklinik Salzburg	Salzburg
Austria	Orthopädie LKH Steyr	Steyr
Austria	Orthopädisches Krankenhaus Gersthof	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew Orthopaedics AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score	The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty	up 10 years after implantation
Primary	WOMAC Osteoarthritis Index	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:[1]; Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties	up 10 years after implantation
Primary	EuroQuol-5D questionnaire	EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal	up 10 years after implantation
Primary	Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects	up to patient's discharge from the hospital / clinic (from surgery up to 7 days after surgery)
Primary	Postoperative AE up to 10 years after the surgery	Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects	up 10 years after implantation
Primary	Survival, Kaplan Meier	Hip implants in situ after 10 years of follow-up	up 10 years after implantation
Secondary	Radiographic changes defined as radiolucent lines,osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.		up 10 years after implantation