NCT00734110
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
The trial's own stop reason says it succeeded, but ClinicalTrials.gov shows no posted results — flagged as a possible orphaned finding.
- Phase
- PHASE4
- Enrollment
- 723
- Sponsor class
- INDUSTRY
- Taxonomy code
- goal_met
What the registry says
“The study achieved the stated objective to record pre & post operative outcomes at a minimum 5 years.”
What real verification found
This is DePuy International's own internal study ID "CT 99/24," officially titled "Multi-Centre Clinical Study of the P.F.C.® Sigma Total Knee System" — a 723-patient, industry-sponsored study registered at Princess Alexandra Hospital NHS Trust (Harlow, UK), running July 2000 to June 2010, whose why_stopped text ("achieved the stated objective to record pre & post operative outcomes at a minimum 5 years") is a routine post-market-surveillance closure note, not a discrete finding. I could not find any peer-reviewed publication, abstract, or conference presentation tied to this specific trial's own dataset. Checks performed: - Direct CT.gov API record: no references/publications field populated, hasResults=false. - Targeted searches combining the trial's specific identifiers (723 patients, Princess Alexandra Hospital, "CT 99/24," DePuy International, "multi-centre") turned up nothing matching. - Cross-checked the sibling DePuy PFC Sigma trials registered in the same NCT block (NCT00734019 cobalt-chrome variant, NCT00733369 RP-F vs RP) — same pattern: no results posted, no linked publications. - Checked whichmedicaldevice.com's independent "clinical evidence" aggregator page for the DePuy PFC Sigma system, which lists 6 other PFC Sigma outcome publications (National Joint Registry 2014, Knee Surg Relat Res 2012, Clin Orthop Surg 2012, J Bone Joint Surg Br 2012 x2, J Arthroplasty 2013) — none of them is this trial; this specific 723-patient/Princess Alexandra cohort is absent from that compiled evidence base too. - Ruled out the most likely-looking candidate, Clayton et al. 2006 "Five-year results of the Sigma total knee arthroplasty" (212 knees/180 patients) — confirmed via PubMed that its authors are from Queen Margaret's Hospital, Dunfermline, Scotland, a different institution/cohort/start date (Oct 1998, not July 2000), not this trial. The PFC Sigma implant itself is one of the most heavily studied knee systems in the world (dozens of independent single- and multi-center outcome papers exist), so the general clinical question "does PFC Sigma have good long-term outcomes" is well answered in the literature — but by other cohorts, not by this trial's own 723-patient dataset. The pattern here (industry post-market surveillance study, single sponsor-facing internal ID, no journal DOI, no PubMed hit, absent from a device-specific evidence compilation that does catalog other studies) is consistent with data collected for regulatory/company purposes and never separately written up, i.e., a genuinely-unused positive result rather than a hidden publication I simply failed to find.
Full search & fetch trail
7 WebSearch queries (direct NCT ID, PFC Sigma 5-year outcomes, "PFC Sigma"+723/multicentre/Harrow, Princess Alexandra Hospital + PFC Sigma, "P.F.C. Sigma"+DePuy International+multicentre, Mahaluxmivala/Princess Alexandra Sigma outcomes, "CT 99/24" DePuy Sigma) + 4 WebFetch calls (CT.gov study page, CT.gov API v2 record for NCT00734110, CT.gov API v2 record for sibling trial NCT00734019, PubMed abstract for Clayton et al. 2006, whichmedicaldevice.com PFC Sigma evidence aggregator).