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NCT01578408
Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
NA trial testing Total Hip Arthroplasty in Femoral Neck Fractures in 109 participants. Completed in 19 February 2020.
9 March 2018
Quick facts
| Lead sponsor | Sahlgrenska University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 109 |
| Start date | 11 May 2010 |
| Primary completion | 9 March 2018 |
| Estimated completion | 19 February 2020 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Total Hip Arthroplasty
- Cemented Lubinus SPII stem (control arm)
- Uncemented HA Coated Corail stem
Conditions studied
- Femoral Neck Fractures — all drugs for Femoral Neck Fractures →
Sponsor
Sahlgrenska University Hospital
Who can join
Adults 60 to 85, any sex, with Femoral Neck Fractures. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this prospective randomized study is to compare the quality of treatment between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures. Our hypothesis is that an uncemented option spares the patient the operative load of the cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also perhaps reduces the postoperative cognition strain and improves mobilization parameters. If the uncemented option has the same excellent fixation in poor bone stock, as in the case of these osteopenic fractures, and also has the same good clinical outcome, it would be a viable standard option for the treatment of dislocated femoral neck fractures.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Arthroplasties for hip fracture in adults.
Lewis SR, Macey R, Parker MJ, Cook JA, et al · · 2022 · cited 54× · PMID 35156194 · DOI 10.1002/14651858.cd013410.pub2 -
Surgical interventions for treating intracapsular hip fractures in older adults: a network meta-analysis.
Lewis SR, Macey R, Stokes J, Cook JA, et al · · 2022 · cited 23× · PMID 35156192 · DOI 10.1002/14651858.cd013404.pub2 -
Cochrane in CORR®: Arthroplasties for Hip Fractures in Adults.
Bzovsky S, Bhandari M. · · 2022 · PMID 35512054 · DOI 10.1097/corr.0000000000002236
Verify or expand the search:
- PubMed search for NCT01578408
- 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 Femoral Neck Fractures
Currently open trials in the same condition.
- NCT07442721 — Sacral ESPB vs. PENG Block for Hip Hemiarthroplasty Analgesia · NA · recruiting
- NCT07244211 — MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP) · NA · recruiting
- NCT07346885 — Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery · NA · active not recruiting
- NCT06937138 — Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation · NA · recruiting
- NCT07299370 — Open vs Closed Reduction in Femoral Neck Fractures Using Anterolateral vs Direct Lateral Approach · NA · active not recruiting
Other Sahlgrenska University Hospital trials
Trials by the same sponsor.
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- NCT07524608 — Implementing an Evidence-based, Standardized Care Bundle Targeting Register Nurses and Anaesthesiologists, to Enhance Pa · not yet recruiting
- NCT07498959 — Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer · NA · recruiting
- NCT06896578 — Latitude - Lateral Lymph Node Attitude Study · NA · not yet recruiting
- NCT07035600 — Walking and Sitting Difficulties After Rectal Cancer Surgery · NA · not yet recruiting
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 NCT01578408 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sahlgrenska University Hospital
- Last refreshed: 24 September 2020
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/NCT01578408.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing