An interventional study of ConforMIS custom total knee in Knee Arthroplasty, Total, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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).
The experimental design was changed based on enrollment hurdles to be a single cohort observational study where ConforMIS patients were enrolled and followed for 6 months with 6 minute walk used as the primary outcome measure.
University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who receive a ConforMIS custom total knee implant.
Device: ConforMIS custom total knee
Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
Distance Measured During 6-minute Walk Test
Subjects will walk for 6 minutes and the distance covered will be measured in feet.
Time frame: 6 months
| Milestone | ConforMIS | Off-the-shelf |
|---|---|---|
| Started | 28 | 0 |
| Completed | 23 | 0 |
| Not completed | 5 | 0 |
Subjects will walk for 6 minutes and the distance covered will be measured in feet.
| feet | ConforMIS |
|---|---|
| Distance Measured During 6-minute Walk Test | 1060 ± 373 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ConforMIS | — | 0/28 (0%) | 1/28 (3.6%) |
| Off-the-shelf | — | — | — |
| Event | ConforMIS | Off-the-shelf |
|---|---|---|
| knee stiffnessMusculoskeletal and connective tissue disorders | 1/28 | — |
| Age, Categorical(Participants) | ConforMIS | Off-the-shelf | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 19 | — | 19 |
| >=65 years | 9 | — | 9 |
| Sex: Female, Male(Participants) | ConforMIS | Off-the-shelf | Total |
|---|---|---|---|
| Female | 18 | — | 18 |
| Male | 10 | — | 10 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University of Missouri-Columbia