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NCT03724058
Fixation and Stability of the Trident® II Clusterhole HA Shells
NA trial testing Trident® II Clusterhole HA Acetabular Shell in Hip Replacement Arthroplasty in 87 participants. Participants enrolled and being followed up; not accepting new ones.
5 June 2023
Quick facts
| Lead sponsor | Region Skane |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 87 |
| Start date | 6 February 2019 |
| Primary completion | 5 June 2023 |
| Estimated completion | 11 May 2031 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Trident® II Clusterhole HA Acetabular Shell
- Trident® Hemispherical Acetabular Shell
Conditions studied
- Hip Replacement Arthroplasty — all drugs for Hip Replacement Arthroplasty →
Sponsor
Region Skane — full company profile →
Who can join
Adults 40 to 75, any sex, with Hip Replacement Arthroplasty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the Trident® II project is to introduce a cup system that modernizes and streamlines Stryker's acetabular shell portfolio. The Trident® II Clusterhole HA Shell combines the history of Stryker's Trident® shells with plasma spray CpTi with HA coating. Plasma spray coating and HA is considered to be the gold standard in orthopaedics today. This coating will help the cup to achieve early stability and long term fixation. One of the causes for implant failure is loosening and osteolysis. Osteolysis can be triggered when metal or polyethylene wear particles from the implant or bearing surfaces migrate between implant and surrounding host bone tissue. With the development of sequential irradiated and annealed highly crosslinked polyethylene (X3) wear rates (mean proximal, 2-dimensional and 3-dimensional) have been substantially reduced to 0.001 mm/y, calculated between 1 year and 5 years. The Trident® II Clusterhole HA shells have a plasma sprayed CpTi coating compared to the arc-deposition CpTi coating on legacy Trident® shells, both designed to allow bone ongrowth. With this study the investigators want to prove equivalent implant fixation of both type of cups. The primary objective is the assessment of prosthetic fixation and migration results after two years of the Trident® II Clusterhole HA shell compared to the legacy Trident® Hemi HA shell by means of RSA. It is hypothesized that they will perform equally. The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03724058
- Europe PMC full search
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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 NCT03724058 (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 Region Skane
- Last refreshed: 4 September 2025
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/NCT03724058.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing