Scaphoid Non-union Advanced Collapse (SNAC Wrist)NCT06808594
The Use of Adaptive Proximal Scaphoid Implant (APSI): Long Term Follow-up
A study testing APSI prosthesis implant in people with Scaphoid Non-union Advanced Collapse (SNAC Wrist), run by Azienda Ospedaliera Universitaria Integrata Verona.
Trial summary
Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Scaphoid Non-union Advanced Collapse (SNAC Wrist)
- What is being tested?
- APSI prosthesis implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 1999to 31 Dec 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;
- collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.
Who cannot join
- patients for whom it was not possible to obtain informed consent to the processing of personal data.
About this study
Official title: The Use of APSI: Long Term Follow-up
Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques.
- Being tested
- APSI prosthesis implant
- Keywords
- osteoarthritis, arthroplasty, Scaphoid fracture, Pyrocarbon, Bone implant
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSI prosthesis implantDevice
The adaptative proximal scaphoid implant (APSI) is a pyrocarbon partial scaphoid prosthesis, ovoid and unfixed, which replaces the proximal pole of the scaphoid and allows adaptative mobility in the movements of the first chain and restores the geometry of the carpus, thus preventing the evolution in SNAC (Scaphoid Non-union Advanced Collapse). Pyrocarbon has good compatibility with joint cartilage and bone, a modulus of elasticity similar to bone minimizing stress shielding effects and resorption. The implant is designed with two radii of curvature: in the frontal plane, the smaller radius of curvature corresponds to the scaphoid fossa, and the larger radius of curvature is directed anteroposteriorly to the transverse plane. When it's correctly positioned, the smallest radius of the curvature is visible in the anteroposterior view, whereas it's greater in the lateral view. These two axes of the implant make it adaptable to the kinematics of the wrist.
| Study group | Role | What they receive |
|---|---|---|
| Long term follow-up of patients treated with APSI | Experimental | Long-term clinical and radiographic outcomes in patients undergoing APSI (Adaptive Proximal Scaphoid Implant); evaluation of wrist strength and ROM (Range of Motion) on the operated side compared with the healthy side; evaluation of daily, work and sports autonomy with DASH (Disabilities of the Arm, Shoulder, and Hand) and PRWE (Patient Rated Wrist Evaluation) questionnaires and evaluating the return to normal daily, work and sports activities pre-surgery; quantification of pain at the site of surgery. Receives: Device: APSI prosthesis implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic outcome
X-Rays showed that all the implants were correctly positioned, without any particular or evident erosion of the surrounding bone structures. A pattern of moderate or non-severe degree of arthrosis of the wrist could generally be found. By comparing the X-rays taken at the follow-up, it was possible to detect a general slight evolution of the arthritic in the wrist compared to what was visible at the beginning of the treatment, in all the patients.
Measured: Through study completion, an average of 17 year
Secondary outcomes (3)
DASH (Disabilities of the Arm, Shoulder, and Hand)
The DASH is a self-administered questionnaire of over 30 questions designed to measure function and symptoms in patients with any musculoskeletal disorder of the upper limb. MAX 100, MIN 0
Measured: Through study completion, an average of 17 year
PRWE (Patient Rated Wrist Evaluation)
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. MAX 50, MIN 0
Measured: Through study completion, an average of 17 year
VAS (Visual Analogue Scale)
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. MAX 10, MIN 0
Measured: Through study completion, an average of 17 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Dec 1999
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scaphoid Non-union Advanced Collapse (SNAC Wrist)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective study
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Corain, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808594
- Sponsor's protocol ID
- prog.74 CET prot.67418
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Database of evaluated patients
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of APSI: Long Term Follow-up
- ClinicalTrials.gov ID
- NCT06808594
- Acronym / sponsor ID
- prog.74 CET prot.67418
- Keywords
- osteoarthritis, arthroplasty, Scaphoid fracture, Pyrocarbon, Bone implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Dec 1999 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 Feb 2025 (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.
Scaphoid proximal pole fracture with avascular necrosis is a complex surgical problem. In some cases, it's possible to perform a scaphoid hemiarthroplasty with an adaptative proximal scaphoid implant (APSI), made of pyrocarbon, replacing the necrotic proximal pole. APSI allows an early mobilization of the wrist, an optimal recovery of strength and a rapid return to normal daily and work activities without limitations. This implant delays palliative and more invasive surgical treatments in patients that are generally young with high functional demands. The investigators have performed a long-term follow up (with a mean follow-up of 17 years) of the early cases of APSI implant performed, starting from 1999. Radiographic and clinical strength recovery, along with subjective outcomes, have been shown to be good, with a rapid return to daily and work activities, indicating that APSI implants are a good alternative to traditional and invasive techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective study
| Arm | Type | Receives |
|---|---|---|
| Long term follow-up of patients treated with APSI | Experimental | Device: APSI prosthesis implantLong-term clinical and radiographic outcomes in patients undergoing APSI (Adaptive Proximal Scaphoid Implant); evaluation of wrist strength and ROM (Range of Motion) on the operated side compared with the healthy side; evaluation of daily, work and sports autonomy with DASH (Disabilities of the Arm, Shoulder, and Hand) and PRWE (Patient Rated Wrist Evaluation) questionnaires and evaluating the return to normal daily, work and sports activities pre-surgery; quantification of pain at the site of surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients who underwent APSI implant surgery in the period from December 1999 to December 2016, with surgery performed via dorsal or volar approach in the case of previous surgical access;
- collection of informed consent to the processing of personal data by the Patients contacted in order to be included in the study.
Key exclusion criteria (1 listed)
- patients for whom it was not possible to obtain informed consent to the processing of personal 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 |
|---|---|---|
| APSI prosthesis implantThe adaptative proximal scaphoid implant (APSI) is a pyrocarbon partial scaphoid prosthesis, ovoid and unfixed, which replaces the proximal pole of the scaphoid and allows adaptative mobility in the movements of the first chain and restores the geometry of the carpus, thus preventing the evolution in SNAC (Scaphoid Non-union Advanced Collapse). Pyrocarbon has good compatibility with joint cartilage and bone, a modulus of elasticity similar to bone minimizing stress shielding effects and resorption. The implant is designed with two radii of curvature: in the frontal plane, the smaller radius of curvature corresponds to the scaphoid fossa, and the larger radius of curvature is directed anteroposteriorly to the transverse plane. When it's correctly positioned, the smallest radius of the curvature is visible in the anteroposterior view, whereas it's greater in the lateral view. These two axes of the implant make it adaptable to the kinematics of the wrist. | Device | Long term follow-up of patients treated with APSI |
Primary outcome
Radiographic outcome
Time frame: Through study completion, an average of 17 year
X-Rays showed that all the implants were correctly positioned, without any particular or evident erosion of the surrounding bone structures. A pattern of moderate or non-severe degree of arthrosis of the wrist could generally be found. By comparing the X-rays taken at the follow-up, it was possible to detect a general slight evolution of the arthritic in the wrist compared to what was visible at the beginning of the treatment, in all the patients.
3 secondary outcomes
DASH (Disabilities of the Arm, Shoulder, and Hand)
Time frame: Through study completion, an average of 17 year
PRWE (Patient Rated Wrist Evaluation)
Time frame: Through study completion, an average of 17 year
VAS (Visual Analogue Scale)
Time frame: Through study completion, an average of 17 year
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 5 Feb 2025.
- Individual participant dataSharing planned: Yes. Database of evaluated patients
Related trials for Scaphoid Non-union Advanced Collapse (SNAC Wrist)
Not yet recruiting
Lunocapitate Fusion in Snac Wrist
Snac Wrist
RecruitingObservational study
The KinematX Midcarpal Total Wrist Arthroplasty Registry
Scapholunate Advanced Collapse (SLAC), Scapholunate Crystalline Advanced Collapse (SCAC)
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.
Questions about this trial
What is this clinical trial studying?
A study testing APSI prosthesis implant in people with Scaphoid Non-union Advanced Collapse (SNAC Wrist), run by Azienda Ospedaliera Universitaria Integrata Verona.
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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Radiographic outcome (time frame: Through study completion, an average of 17 year). 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 5 Feb 2025.