N/A
Completed N=28
iTotal Pilot Study of ConforMIS Custom Total Knee Implant
Knee Arthroplasty, Total
Source: ClinicalTrials.gov NCT02186587 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Distance Measured During 6-minute Walk Test — 1060 feet
Summary
To compare the outcomes of patients receiving the ConforMIS custom total knee implant to the outcomes of patients who receiving an off-the-shelf total knee implant.
Hypothesis: Patient-specific, custom total knee implants manufactured from patient CT data, and implanted with CT-navigated custom instruments will show faster functional recovery, including gait and patient functional outcome scores, when compared to standard, off-the-shelf total knee components inserted with non-navigated instruments (the present standard of care in total knee surgery).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Measured During 6-minute Walk Test |
1060 | — |
Eligibility Criteria
Inclusion Criteria
- undergoing total knee arthroplasty
Exclusion Criteria
- BMI >40
Data sourced from ClinicalTrials.gov (NCT02186587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.