An observational study in Flat Foot, Lateral Column Lengthening and Medial Cuneiform Osteotomy, sponsored by Paragon 28. Withdrawn. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by Paragon 28 (part of Zimmer Biomet) · Observational
Evaluate clinical healing and radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Subjects who receive one or more TITAN 3-D™ Wedges will obtain satisfactory levels of clinical healing and radiographic maintenance of correction at 6 months.
173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.
Browse Flatfoot studies →Paragon 28 is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
First submitted before Paragon 28 became part of Zimmer Biomet.
Counted across the registry records on this site, refreshed daily.
The study population will include males and females of all ages. Furthermore, it is likely that the majority of subjects enrolled in this study suffer from a flatfoot deformity; however, this study will not be restricted to only those diagnosed with flatfoot.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who receive one or more Titan 3D wedge(s).
Device: Titan 3D Wedge System
Each subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure.
Clinical Healing
Evaluate clinical healing following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Clinical healing is defined as lack of pain over the osteotomy site.
Time frame: 6 Months
Radiographic Maintenance of Correction
Evaluate radiographic maintenance of correction following an LCL procedure or medial cuneiform osteotomy (Cotton) at 6 months following the use of the TITAN 3-D™ Wedge. Radiographic maintenance of correction is defined as the absence of a clinically relevant change in radiographic measures across post-operative time points.
Time frame: 6 Months
Time to clinical/radiographic healing (union)
Evaluate time to clinical/radiographic healing (union vs. non-union) after a Titan 3D wedge procedure
Time frame: 24 Months
Clinical complications
Complications due to the procedure
Time frame: 24 Months
Maintenance of implant position
Time frame: 24 Months
Maintenance of anatomical alignment
Time frame: 24 Months
Determine bone reaction, if any, to the device such as overgrowth or cystic lesions
Time frame: 24 Months
Determine rate of removal of the device and subsequent healing
Time frame: 24 Months
Change in anatomical and radiographic angular/positional alignment before and after an LCL procedure and/or medial cuneiform osteotomy using a TITAN 3-D™ Wedge
Time frame: 24 Months
Change in VAS Pain Score across multiple time points
Visual Analog Scale (VAS). Line from 0 (no pain) to 10 (worst pain). Patient reported.
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in AOFAS Ankle-Hindfoot and/or Midfoot Score across multiple time points
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot clinical score. Pain: 0-40 points Function: 0-50 points Alignment: 0-10 points Total Score (sum): 0-100 points (higher score indicates better outcomes) American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot clinical score. Pain: 0-40 points Function: 0-45 points Alignment: 0-15 points Total Score (sum): 0-100 points (higher score indicates better outcomes)
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Intensity Score across multiple time points
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score, Item Bank v1.0, SF 3a. Raw Score Range: 3 (no pain) to 15 (very severe pain)
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Mobility Score across multiple time points
Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility Score, Item Bank v2.0. Raw Score Range: 15 (high level of difficulty) to 120 (no difficulty)
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Change in PROMIS Pain Interference Score across multiple time points
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score, Item Bank v1.0, SF 6a. Raw Score Range: 6 (no interference) to 30 (high level of interference)
Time frame: Pre-operatively, 2 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 24 months
Compare the outcomes and complication rates of TITAN 3-D™ Wedges with previously published outcomes of historical controls, allograft bone and autograft bone
Time frame: 24 Months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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