Autopsy report · NCT00733330

Minimally Invasive Total Knee Replacement - Navigated Versus Non-navigated Study

“A sample size recalculation indicated an increase from 154 to 1500 subjects was required so the study stopped as new target was considered unfeasible.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 years 7 months after it had already started.
• Ran for about 5 years 11 months before it stopped.
• 86 participants enrolled.
• Results were posted on the registry 3 years 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

DePuy International

Sponsor type

Industry

Conditions

Osteoarthritis

Interventions

Either P.F.C. Sigma or L.C.S. Complete knee replacement using the conventional surgical approach and manual surgical technique; Either P.F.C. Sigma or L.C.S. Complete knee replacement using minimally invasive surgical approach and computer navigation

Participants

86

Sites

5

Countries

Australia, New Zealand, United States

Trials that died the same way

• Physical Exercise for Augmenting Cognitive Health (PEACH)
  “The study protocol was not feasible. We made several modifications but halted the study prematurely before we met our target sample size goal.” (69% match in meaning)
• Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
  “The number of enrolled subjects did not meet the goal during the study” (68% match in meaning)
• Gastric Accommodation and Gastroesophageal Reflux
  “the study failed in recruiting the required number of subjects (sample size) during its period” (68% match in meaning)
• L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia
  “The study stopped enrollment prior to the initially projected 18 subjects per phase due to lack of funding to continue to recertify the drug and because an adequate number of subjects were enrolled for each phase to analyze pharmacokinetics.” (67% match in meaning)
• The Effect of Buprenorphine Continuation for Patients With Opioid Use Disorder
  “This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.” (66% 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.