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NCT06053060: DYNACUP
Evaluation of the Positioning of the Dynacup Cup "One C" Versus "Standard Dynacup"
NA trial testing Randomisation Standard Dynacup or Dynacup One C in Hip in 300 participants. Completed in 22 March 2023.
22 March 2023
Quick facts
| Lead sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 300 |
| Start date | 21 November 2021 |
| Primary completion | 22 March 2023 |
| Estimated completion | 22 March 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- Randomisation Standard Dynacup or Dynacup One C
Conditions studied
- Hip — all drugs for Hip →
- Arthropathy — all drugs for Arthropathy →
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
Who can join
18 and older, any sex, with Hip or Arthropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The ceramic-ceramic friction pair is widely used today in total hip arthroplasty, including fourth-generation ceramics which show the lowest wear rate. These have considerably reduced the risk of head fracture compared to previous generations; however, the risk of insert rupture persists with rates similar to those of third generation ceramics. These ceramic fractures require complex revision surgery, which brings complications, exposing patients to the risk of third-body wear and tear related to persistent post-surgical debris. They are frequently due to an incorrect assembly of the ceramic causing intraoperative or early postoperative rupture. To fix this, manufacturers have developed pre-assembled cups in the factory. The Dynacup One C cup developed by Corin® corresponds to the pre-assembled version of the Dynacup cup, making it possible to eliminate the risk of anomaly during intraoperative assembly linked to the human factor and to offer patients with very small cups an adapted ceramic implant. A single study with a small sample compared the two implants (pre-assembled version \[vs\] modular version) clinically, radiologically and functionally without showing any significant difference. The lack of data in the literature comparing these two implants motivated us to conduct a randomized comparative study on a large sample of patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06053060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hip
Currently open trials in the same condition.
- NCT02285868 — ATI Evidence-based Guide Investigating Clinical Services · active not recruiting
- NCT05613439 — The Fast-track Centre for Hip and Knee Replacement Database · recruiting
Other Groupe Hospitalier Diaconesses Croix Saint-Simon trials
Trials by the same sponsor.
- NCT06872437 — Evaluation of the Efficacy of Therapeutic Infiltrations of the Pudendal Nerve, Performed Under Neurostimulation on Pain, · Phase 3 · recruiting
- NCT06602349 — EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION · NA · recruiting
- NCT07190729 — Monocentric Randomised Controlled Trial to Assess Whether Virtual Reality Reduces the Use of Hypnotic Agents During IVF/ · NA · completed
- NCT06052982 — Evaluation of Blood Loss During Knee Arthroplasty · NA · completed
- NCT06054711 — Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses · NA · unknown
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 NCT06053060 (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 Groupe Hospitalier Diaconesses Croix Saint-Simon
- Last refreshed: 25 September 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/NCT06053060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing