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Sponsor decided to pursue an alternative study prior to subject enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titan 3-D Wedge System | Subjects who receive one or more Titan 3D wedge(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titan 3D Wedge System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical/radiographic healing (union) | Evaluate time to clinical/radiographic healing (union vs. non-union) after a Titan 3D wedge procedure | 24 Months |
| Clinical complications | Complications due to the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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|
| 24 Months |
| Maintenance of implant position | 24 Months |
| Maintenance of anatomical alignment | 24 Months |
| Determine bone reaction, if any, to the device such as overgrowth or cystic lesions | 24 Months |
| Determine rate of removal of the device and subsequent healing | 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 | 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. | 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) | 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) | 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) | 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) | 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 | 24 Months |
| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |