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NCT04748458: RetroCone

Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty Due to Congenital Hip Pathologies

Completed Results posted Last updated 22 March 2022
What this trial tests

trial testing Conical tapered stem in Dysplasia; Hip in 85 participants. Completed in 2 October 2021.

Timeline
17 July 2020
Primary endpoint
1 October 2021
2 October 2021

Quick facts

Lead sponsorIstituto Ortopedico Rizzoli
StatusCompleted
Study typeOBSERVATIONAL
Enrollment85
Start date17 July 2020
Primary completion1 October 2021
Estimated completion2 October 2021
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

18 and older, any sex, with Dysplasia; Hip or Prosthesis Survival. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Harris Hip Score Primary · 15 months

Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

GroupValue95% CI
Congenital Hip Pathologies89.8± 6.8
Survival Rate Primary · 15 months

Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.

GroupValue95% CI
Congenital Hip Pathologies98.992.5 – 99.8
Radiographic Cup Osseointegration Primary · 15 months

Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).

GroupValue95% CI
Congenital Hip Pathologies98
Radiographic Stem Osseointegration Primary · 15 months

Osseointegrated stems described according to Engh's criteria

GroupValue95% CI
Congenital Hip Pathologies99

Sponsor's own description

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Istituto Ortopedico Rizzoli trials

Trials by the same sponsor.

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Data sources for this page

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/NCT04748458.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing