TalusRECLAIMNCT05231304
Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
An observational study of Talus and Ankle Arthropathy, run by Restor3D at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Talus, Ankle Arthropathy
- What is being tested?
- Total Talus Replacement (TTR), Total Ankle Total Talus Replacement (TATTR) and Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2022to 19 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who underwent surgery involving a TTR implant with or without total ankle replacement and/or subtalar fusion between 1/1/2019 and 01/28/2022 will be will be included in this retrospective review. Patients with at least one postoperative follow-up visit will be included in this study. Only data in existence as of 01/28/2022 will be collected.
Who may be able to join
- >18 Years of Age
- Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.
Who cannot join
- No available postoperative data
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Bellevue Hospital
Bellevue, Ohio, 44811
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
About this study
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.
- Conditions
- Talus, Ankle Arthropathy
- Being tested
- Total Talus Replacement (TTR), Total Ankle Total Talus Replacement (TATTR), Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ), Total Talus Replacement + Subtalar Fusion (TTR + STJ)
- Keywords
- Retrospective Study, Ankle Joint, Talus, Arthrodesis, Printing, Three-Dimensional, Joint Prosthesis, Prosthesis Design
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Talus Replacement (TTR)Procedure or surgery
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device.
Total Ankle Total Talus Replacement (TATTR)Procedure or surgery
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 or surgery
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 or surgery
Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion.
| Study group | Role | What they receive |
|---|---|---|
| Total Talus Replacement | Not described Receives: Procedure: Total Talus Replacement (TTR) | |
| Total Ankle Total Talus Replacement | Not described Receives: Procedure: Total Ankle Total Talus Replacement (TATTR) | |
| Total Ankle Total Talus Replacement + Subtalar Fusion | Not described Receives: Procedure: Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ) | |
| Total Talus Replacement + Subtalar Fusion | Not described Receives: Procedure: Total Talus Replacement + Subtalar Fusion (TTR + STJ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain from pre-operative baseline
Primary probable benefit endpoint is improvement in pain at 12 months from preoperative baseline.
Measured: 12-months
Secondary outcomes (5)
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Measured: 3 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Measured: 6 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Measured: 12 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Measured: 24 months
Improvement in Patient Reported Outcomes
Secondary probably benefit endpoints will include patient reported functional outcome measures
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start5 Apr 2022
- Primary completion6 Jan 2023
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231304
- Sponsor's protocol ID
- restor3d-002
- Acronym
- RECLAIM
- Status last verified
- Feb 2024
- First submitted
- 27 Jan 2022
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
- ClinicalTrials.gov ID
- NCT05231304
- Acronym / sponsor ID
- RECLAIM / restor3d-002
- Conditions
- Talus, Ankle Arthropathy
- Keywords
- Retrospective Study, Ankle Joint, Talus, Arthrodesis, Printing, Three-Dimensional, Joint Prosthesis, Prosthesis Design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total Talus Replacement | – | Procedure: Total Talus Replacement (TTR) |
| Total Ankle Total Talus Replacement | – | Procedure: Total Ankle Total Talus Replacement (TATTR) |
| Total Ankle Total Talus Replacement + Subtalar Fusion | – | Procedure: Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ) |
| Total Talus Replacement + Subtalar Fusion | – | Procedure: Total Talus Replacement + Subtalar Fusion (TTR + STJ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who underwent surgery involving a TTR implant with or without total ankle replacement and/or subtalar fusion between 1/1/2019 and 01/28/2022 will be will be included in this retrospective review. Patients with at least one postoperative follow-up visit will be included in this study. Only data in existence as of 01/28/2022 will be collected.
Key inclusion criteria (2 listed)
- >18 Years of Age
- Patient underwent surgery involving a total talus replacement implant between 1/1/2019 and 01/28/2022.
Key exclusion criteria (1 listed)
- No available postoperative data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Talus Replacement (TTR)Surgical implantation of restor3d's patient-specific custom Total Talus Replacement device. | Procedure or surgery | Total Talus Replacement |
| Total Ankle Total Talus Replacement (TATTR)Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device. | Procedure or surgery | Total Ankle Total Talus Replacement |
| Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)Surgical implantation of restor3d's patient-specific custom Total Ankle Total Talus Replacement (TATTR) device with concurrent subtalar fusion. | Procedure or surgery | Total Ankle Total Talus Replacement + Subtalar Fusion |
| Total Talus Replacement + Subtalar Fusion (TTR + STJ)Surgical implantation of restor3d's patient-specific custom Total Talus Replacement (TTR) device with concurrent subtalar fusion. | Procedure or surgery | Total Talus Replacement + Subtalar Fusion |
Primary outcome
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.
5 secondary outcomes
Improvement in Patient Reported Outcomes
Time frame: 3 months
Improvement in Patient Reported Outcomes
Time frame: 6 months
Improvement in Patient Reported Outcomes
Time frame: 12 months
Improvement in Patient Reported Outcomes
Time frame: 24 months
Improvement in Patient Reported Outcomes
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Related trials for Talus
Enrolling by invitationPhase 3
A RCT of Collagen Scaffold for the Repair of Talus Cartilage Injury
Cartilage Defects, Talus Osteochondral Defect
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Not yet recruitingPhase 3
Astragalus for Symptomatic Alleviation in High-grade Lymphoma
High-grade Lymphoma
RecruitingObservational study
Patient Specific Talus Spacer Post Approval Study
Avascular Necrosis of the Talus
Active, not recruiting
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus
Osteochondral Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Talus and Ankle Arthropathy, run by Restor3D at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in pain from pre-operative baseline (time frame: 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.