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OpenTrials
Completed

NCT Number: NCT05231304

Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement

This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion. This study seeks to analyze the clinical and radiographic outcomes of TTR implant recipients and generate additional data on the safety and benefit of the TTR implant.

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Key information

Conditions

Talus Ankle Arthropathy Ankylosis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic Institute of Western Kentucky, Paducah, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 Years of Age
  • Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.

Exclusion criteria

  • No available postoperative data

Treatment and study plan

Total Talus Replacement (TTR)

Procedure

Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.

Total Ankle Total Talus Replacement (TATTR)

Procedure

Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device.

Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)

Procedure

Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion.

Total Talus Replacement + Subtalar Fusion (TTR + STJ)

Procedure

Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.

Primary outcomes

  1. Improvement in pain from pre-operative baseline

    Time frame: 12-months

    Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.

Secondary outcomes

  1. Improvement in Patient Reported Outcomes

    Time frame: 3 months

    Secondary probably benefit endpoints will include patient reported functional outcome measures

  2. Improvement in Patient Reported Outcomes

    Time frame: 6 months

    Secondary probably benefit endpoints will include patient reported functional outcome measures

  3. Improvement in Patient Reported Outcomes

    Time frame: 12 months

    Secondary probably benefit endpoints will include patient reported functional outcome measures

  4. Improvement in Patient Reported Outcomes

    Time frame: 24 months

    Secondary probably benefit endpoints will include patient reported functional outcome measures

  5. Improvement in Patient Reported Outcomes

    Time frame: 36 months

    Secondary probably benefit endpoints will include patient reported functional outcome measures

Other outcomes

  1. Subsequent Surgical Intervention

    Time frame: Up to 3 years.

    The primary safety outcome measure is rate of subsequent surgical intervention (SSI), as defined as any surgical procedure or service required after the initial implant of the TTR device.

  2. Adverse Events (AEs)/Serious Adverse Events (SAEs)

    Time frame: Up to 3 years.

    Safety outcome measures by occurrence of adverse events (AEs), device- or procedure related AEs, and serious AEs.

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Acronym: RECLAIM

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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