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NCT04121585: SL-PLUS HA
Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft
trial testing Total Hip Arthroplasty in Primary Total Hip Arthroplasty in 100 participants. Terminated before completion.
27 October 2020
Quick facts
| Lead sponsor | Smith & Nephew Orthopaedics AG |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 12 June 2009 |
| Primary completion | 27 October 2020 |
| Estimated completion | 27 October 2020 |
| Sites | 2 locations across Austria |
Drugs / interventions tested
- Total Hip Arthroplasty
Conditions studied
- Primary Total Hip Arthroplasty — all drugs for Primary Total Hip Arthroplasty →
Sponsor
Smith & Nephew Orthopaedics AG
Who can join
Adults 18 to 75, any sex, with Primary Total Hip Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04121585
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Total Hip Arthroplasty
Trials testing the same drug.
- NCT06640764 — Multicentre SMS Study - FR · recruiting
- NCT06499038 — The Ace Avanteon Study - A Randomized Controled Trial · NA · recruiting
- NCT06342843 — Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH) · NA · recruiting
- NCT07409909 — Total Hip Arthroplasty Versus Bipolar Hemiarthroplasty for Treatment of Intracapsular Displaced Fracture Neck Femur in E · NA · completed
- NCT05357664 — PINNACLE® DM RSA Study · NA · terminated
Other recruiting trials for Primary Total Hip Arthroplasty
Currently open trials in the same condition.
- NCT07337642 — Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty · NA · recruiting
Other Smith & Nephew Orthopaedics AG trials
Trials by the same sponsor.
- NCT04992078 — A Comparison of Patients Receiving a Unicompartmental Knee Replacement With Robotic Assistance or With Conventional Inst · NA · withdrawn
- NCT04989998 — Patient Outcomes Using HIP7 Software as Compared to Conventional THA · NA · withdrawn
- NCT04976972 — A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation · NA · withdrawn
- NCT03877484 — Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border · completed
- NCT03691298 — Safety and Performance of the SUTUREFIX ULTRA and SUTUREFIX CURVED Suture Anchors in Shoulder and Hip Arthroscopic Repai · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04121585 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew Orthopaedics AG
- Last refreshed: 1 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04121585.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing