Interphalangeal; Osteoarthritis, Proximal (Bouchard)NCT04658459
Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty
An observational study of Interphalangeal; Osteoarthritis, Proximal (Bouchard), run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interphalangeal; Osteoarthritis, Proximal (Bouchard)
- What is being tested?
- Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to Jul 2021
- 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: patients who have undergone a proximal interphalangeal joint arthroplasty with the Tactys prosthesis between january 2015 and january 2020 in the Chirugie de la main service in the Centre chirurgical Emile Gallé in Nancy
Who may be able to join
- one or more proximal interphalangeal joint arthroplasty of long fingers with the Tactys prosthesis
- between january 2015 to january 2020
- major
- centre chirurgical emile gallé, centre hospitalier régional universitaire de Nancy
Who cannot join
- minor
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire
Nancy, Meurthe ET Moselle, 54000
Aude LOZANO, resident, 0611434813, a.lozano@chru-nancy.fr
About this study
Official title: Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.
Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.
Read the detailed description
The inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the Tactys prothesis between january 2015 to january 2020 in the Centre Chirurgical Emile Gallé in Nancy.
The functional results evaluated are range of motion, force, pain, functional score as Quick DASH and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence.
Data is registered from the medical folder of every patient.
- Being tested
- Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis
- Keywords
- tactys prosthesis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Interphalangeal Joint Arthroplasty with the Tactys ProsthesisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Results at short term follow up | Functional and Radiological results at short-term follow up (one year at least) Receives: Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis | |
| Results at middle term follow up | Functional and Radiological results at the last follow up of the patient (2 years at least) Receives: Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion in degrees
measurement of range of motion in degrees
Measured: minimal one year post-operative
force in kilograms
measurement of force with jamar and pinch tests in kilograms
Measured: minimal one year post-operative
pain with the digital pain scale
measurement of pain with the digital pain scale to zero to ten
Measured: minimal one year post-operative
functional score with the Quick DASH
measurement of the quick-DASH functional score to zeo to hundred
Measured: minimal one year post-operative
Secondary outcomes (2)
register the complication and their apparition in time
Measured: minimal one year post-operative
assess satisfaction
assess the patient's satisfaction : very satisfied, satisfied, moderate, not satisfied
Measured: minimal one year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jan 2015
- Primary completionMar 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interphalangeal; Osteoarthritis, Proximal (Bouchard)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658459
- Sponsor's protocol ID
- 2020PI110
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 8 Dec 2020
- 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 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.
- ClinicalTrials.gov ID
- NCT04658459
- Acronym / sponsor ID
- 2020PI110
- Keywords
- tactys prosthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 Dec 2020 (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.
Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.
Detailed description
The inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the Tactys prothesis between january 2015 to january 2020 in the Centre Chirurgical Emile Gallé in Nancy.
The functional results evaluated are range of motion, force, pain, functional score as Quick DASH and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence.
Data is registered from the medical folder of every patient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Results at short term follow up | – | Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys ProsthesisFunctional and Radiological results at short-term follow up (one year at least) |
| Results at middle term follow up | – | Procedure: Proximal Interphalangeal Joint Arthroplasty with the Tactys ProsthesisFunctional and Radiological results at the last follow up of the patient (2 years at least) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have undergone a proximal interphalangeal joint arthroplasty with the Tactys prosthesis between january 2015 and january 2020 in the Chirugie de la main service in the Centre chirurgical Emile Gallé in Nancy
Key inclusion criteria (4 listed)
- one or more proximal interphalangeal joint arthroplasty of long fingers with the Tactys prosthesis
- between january 2015 to january 2020
- major
- centre chirurgical emile gallé, centre hospitalier régional universitaire de Nancy
Key exclusion criteria (1 listed)
- minor
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 |
|---|---|---|
| Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis | Procedure or surgery | Results at middle term follow up, Results at short term follow up |
Primary outcome
range of motion in degrees
Time frame: minimal one year post-operative
measurement of range of motion in degrees
force in kilograms
Time frame: minimal one year post-operative
measurement of force with jamar and pinch tests in kilograms
pain with the digital pain scale
Time frame: minimal one year post-operative
measurement of pain with the digital pain scale to zero to ten
functional score with the Quick DASH
Time frame: minimal one year post-operative
measurement of the quick-DASH functional score to zeo to hundred
2 secondary outcomes
register the complication and their apparition in time
Time frame: minimal one year post-operative
assess satisfaction
Time frame: minimal one year post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interphalangeal; Osteoarthritis, Proximal (Bouchard), run by Central Hospital, Nancy, France at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aude LOZANO, resident (0611434813, a.lozano@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion in degrees (time frame: minimal one year post-operative). The study lists 4 primary outcomes in all. 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 8 Dec 2020.