Autopsy report · NCT01063751

Tritanium® Primary Acetabular Shell Study

“As longitudinal patient follow-up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements this study intends to support. Termination is not related to any safety concerns with the products.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 5 months before it started.
• Ran for about 12 years 5 months before it stopped.
• 275 participants enrolled.
• Results were posted on the registry 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Stryker Orthopaedics

Sponsor type

Industry

Conditions

Arthroplasty, Replacement, Hip

Interventions

Tritanium® Primary Acetabular Shell

Participants

275

Sites

7

Countries

United States

Trials that died the same way

• PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency
  “The study was terminated by the sponsor prior to planned completion based on a review of the data across indications and overall program considerations. Study termination was not related to participant safety.” (63% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (63% match in meaning)
• Anti-RSV Study in Chinese Patients (ASCENT)
  “The study was terminated early due to COVID-19-related enrollment disruptions, not as a result of any product safety concerns.” (63% match in meaning)
• An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
  “The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study” (63% match in meaning)
• A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
  “The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.” (62% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.