Clinical Trials Logo
  1. Home
  2. Primary Total Hip Arthroplasty
  3. NCT04121585

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

Primary Total Hip Arthroplasty Clinical Trial

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

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04121585
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Terminated
Phase
Start date June 12, 2009
Completion date October 27, 2020
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03968939 - Total Joint Arthroplasty and Sleep Phase 4
Terminated NCT04036071 - Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft
Completed NCT04209426 - Retrospective Observational Cohort Study of SYMBOL CUP DM 2
Enrolling by invitation NCT05313321 - Survival of the Insignia Stem in Total Hip Arthroplasty
Completed NCT03690037 - Investigating the Effect of Intravenous and Oral Tranexamic Acid on Blood Loss After Primary Hip and Knee Arthroplasty Phase 4
Completed NCT04209374 - Retrospective Observational Cohort Study of SYMBOL CUP DM 1
Completed NCT04122157 - Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
Completed NCT04085640 - Obturator Nerve Block in Total Hip Arthrosplasty N/A
Recruiting NCT04319952 - OPS™ With Direct Anterior Approach (DAA)
Completed NCT05072704 - Opioid Free Anesthesia in Total Hip Arthroplasty Phase 3
Completed NCT03973320 - Outcomes After Hypotensive Neuraxial Anesthesia in Total Hip Arthroplasty
Recruiting NCT01495546 - Total Hip Arthroplasty (THA): Early Load Versus Load Late N/A
Terminated NCT02933671 - Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty Phase 4
Completed NCT03956381 - Accuracy of OPS™ Femoral Neck Resection Study