A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf
Public ClinicalTrials.gov record NCT02251522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.
Study identification
- NCT ID
- NCT02251522
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 873 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2014 (Actual)
- Primary completion
- Oct 2016 (Actual)
- Completion
- Dec 2016 (Actual)
- Last update posted
- Oct 25, 2023
2014 – 2016
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Denver-Vail Orthopedics | Parker | Colorado | 80134 | — |
| Institute for Orthopaedic Surgery & Sports Medicine | Fort Myers | Florida | 33919 | — |
| Baptist Health South Florida | Miami | Florida | 33176 | — |
| Coastal Orthopaedic & Sports Medicine Ctr | Port Saint Lucie | Florida | 34996 | — |
| Bethesda Orthopedic | Bethesda | Maryland | 20817 | — |
| Excel Orthopaedic Specialists | Woburn | Massachusetts | 01801 | — |
| Great Lakes Bone & Joint Center | Battle Creek | Michigan | 49015 | — |
| Lederman-Kwartowitz Center for Orthopedics and Sports Medicine | West Bloomfield | Michigan | 48323 | — |
| Orthopaedic Institute of Henderson | Henderson | Nevada | 89052 | — |
| St. Lawrence Health System | Potsdam | New York | 13676 | — |
| Orthopedic Specialties of Spartanburg | Spartanburg | South Carolina | 29303 | — |
| Advanced Orthopedics & Sports Medicine | Cypress | Texas | 77429 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02251522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 25, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02251522 live on ClinicalTrials.gov.