NCT00208390
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
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
- 275
- Sponsor class
- INDUSTRY
- Taxonomy code
- goal_met
What the registry says
“Study closed after the 5 year end-point was reached after a review of the status further to a request from the investigators to discontinue participation.”
What real verification found
This is a DePuy International (Industry)-sponsored Phase 4 post-market surveillance study of the Summit cementless hip stem, run at 5 sites (Bergamo Italy, Shanghai China, Pokfulam Hong Kong, Seoul South Korea, Auckland New Zealand), started Feb 2003, enrolled 275 patients (18-70y), and closed May 2012/terminated 2016 after the pre-specified 5-year endpoint was reached — the "goal_met" flag is really just "the study ran its planned course," not a dramatic efficacy win. No results are posted on the CT.gov record (has_results: false, confirmed via the record itself and the Veeva CTV mirror, which likewise shows only protocol/eligibility data with "no results, linked publications, or specific outcomes"). Targeted PubMed/web searches for the trial ID, the sponsor's internal study number (CT01/25), and the specific site combination turned up nothing. I did find other, independently-registered Summit-stem literature — a 2010 Hip International paper on a separate 485-stem Spanish cohort (García-Cimbrelo et al., 5 Spanish hospitals — different countries, different registration, not this trial), Korean single-center studies (Incheon, 121 patients, retrospective, no CT.gov ID), and Japanese cohort studies — but none of these match this trial's sites, sponsor structure, or patient count, and none cite NCT00208390. whichmedicaldevice.com's evidence page for the Summit system lists this trial only as a bare CT.gov link among its "evidence" entries, not as a completed publication with findings. The Summit stem itself is a mainstream, non-recalled, still-marketed implant (unlike DePuy's ASR, which was recalled) with a well-established literature base from other independent studies and national joint registries (e.g., UK NJR), so the broader clinical question about the device class is reasonably well-answered elsewhere — but this specific trial's own 275-patient, 5-country dataset does not appear to have been written up anywhere findable.
Full search & fetch trail
WebSearch: "NCT00208390 Summit Hip DePuy long-term performance"; "Summit" hip DePuy "5 year" primary total hip replacement multicentre study results publication; "NCT00208390" (exact string); DePuy Summit hip stem long term survivorship outcomes registry 2012-2014; Hip Int 2010 Summit stem "485" multicentre prospective results; Summit hip stem DePuy five year clinical results paper 2013-2015; Summit hip stem Italy China Hong Kong New Zealand Korea multicentre DePuy trial results; Summit hip stem Bergamo Auckland Shanghai Pokfulam Seoul multicentre results publication. WebFetch: clinicaltrials.gov/study/NCT00208390 (raw page + API v2 record for locations/sponsor/dates); whichmedicaldevice.com Summit evidence page; ctv.veeva.com mirror of the CT.gov record; PMC5729164 (Korean Summit stem study, checked for overlap — none found).