Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

Primary Total Hip Arthroplasty Clinical Trial

— SL-PLUS HA  

Official title:

Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04121585
• Other study ID #: D10080-3
• Status: Terminated
• Start date: June 12, 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 SL-PLUS™ stem within an observation study Study design: prospective, multicenter, observational, non-comparative study Study population: 240 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, implant-related complications, revisions; patient questionnaires HOOS and EQ-5D 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. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: October 27, 2020
• Est. primary completion date: October 27, 2020
• 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 SL-PLUS™ 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™ hydroxylapatite coated cement free hip stem

Locations

Country	Name	City	State
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. The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.	up to 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: 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 I off toilet, heavy domestic duties, light domestic duties	up to 10 yeares 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 to 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	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 to 10 years after implantation
Primary	Survival, Kaplan Meier	Hip implants in situ after 10 years of follow-up	up to 10 years after implantation
Secondary	Radiographic changes	Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.	up to 10 years after implantation