Evaluation of the Titan 3-D™ Wedge System

NCT03421665 | Withdrawn FDA Device

• 1 other identifier: P03-SP-0001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Flat Foot; Lateral Column Lengthening; Medial Cuneiform Osteotomy

Keywords

titanium wedge; Evans; Cotton

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (13)

• Time to clinical/radiographic healing (union)

  24 Months

• Clinical complications

  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

Study Arms (1)

Titan 3-D Wedge System

Subjects who receive one or more Titan 3D wedge(s).

Device: Titan 3D Wedge System

Interventions

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.

Titan 3-D Wedge System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• The subject has foot pain/discomfort on the foot in question.
• The subject has activity limitations due to the foot in question.
• The subject agrees to comply with the requirements of the study and complete the study measures.
• The subject (or representative of the subject in the case of a minor) is willing and able to provide written informed consent.
• The subject plans on undergoing an LCL procedure and/or medial cuneiform osteotomy with a TITAN 3-D™ Wedge.

You may not qualify if:

• The subject is pregnant.
• The subject had been previously sensitized to titanium.
• The subject is scheduled for a same day bilateral LCL procedure or medial cuneiform osteotomy procedure.
• The subject is not expected to complete the study according to the investigation plan.
• The subject has been deemed physiologically or psychologically inadequate by the enrolling physician.
• The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated to be non-compliant.

Sponsors & Collaborators

• Paragon 28: lead

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: June 15, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share