Clinical trial NCT04121585: Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft
Official title: Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Primary Total Hip Arthroplasty
Keywords: HA (hydroxylapatite) coated SL-PLUS™ stem
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 240 consecutive cases (HA-coated implants), 60 cases per study site

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Harris Hip Score
timeFrame: up to 10 years after implantation
measure: WOMAC Osteoarthritis Index
timeFrame: up to 10 yeares after implantation
measure: EuroQuol-5D questionnaire
timeFrame: up to 10 years after implantation
measure: Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge
timeFrame: from surgery up to 7 days after surgery
measure: Postoperative AE up to 10 years after the surgery
timeFrame: up to 10 years after implantation
measure: Survival, Kaplan Meier
timeFrame: up to 10 years after implantation
Secondary outcomes:
measure: Radiographic changes
timeFrame: up to 10 years after implantation
Other outcomes:
Locations:
city: Steyr
country: Austria
facility: Orthopädie LKH Steyr
city: Vienna
country: Austria
facility: Orthopädisches Krankenhaus Gersthof
Study officials:
affiliation: Orthopädisches Krankenhaus Gersthof
name: K Zweymüller, Univ. Prof. Dr
role: STUDY_CHAIR
affiliation: Orthopädie LKH Steyr
name: Vinzenz Auersperg, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References: