Complete Tear of Scapholunate LigamentPhase 1CanRASLNCT04980547
Evaluation of the Surgical Proficiency and Effectiveness of the Acumed Scapholunate Repair System in Primary Scapholunate Instability Among Canadians
A Phase 1 study testing ACUMED® Scapholunate Repair System Group in people with Complete Tear of Scapholunate Ligament and Scapholunate Dissociation, run by University of Calgary.
Trial summary
This study is a prospective, multi-centre, non-randomized, and non-blinded follow-up study to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Complete Tear of Scapholunate Ligament, Scapholunate Dissociation
- What is being tested?
- ACUMED® Scapholunate Repair System Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Sep 2025
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has primary, chronic (> 6 weeks) scapholunate instability diagnosed by X-ray, dynamic X-ray, MRI/MRI arthrogram and/or arthroscopy
- Subject is a suitable candidate for RASL repair with the ACUMED® Scapholunate Repair System
- Subject is willing and able to participate in required follow-up visits and can complete study activities.
- Subject provides informed consent
Who cannot join
- Subject has scapholunate advanced collapse wrist arthritis above grade I (styloid only)
- Subject has conditions that would eliminate or tend to eliminate adequate implant support:
- Blood supply limitations;
- Insufficient quantity or quality of bone support (osteoporosis, metabolic disorders which may impair bone formation, tumor, osteomalacia, etc.).
- Subject has mental or neurological conditions which impair their ability or willingness to restrict activities that may put the affected limb at risk.
- Subject has physical conditions that tend to place extreme loads on the implants (Charcot joints, muscle deficiencies etc.).
Show all 12Show fewer
- Subject has neuromuscular dysfunctions (paralysis, myolysis, etc.) which could cause instability of the wrist after surgery
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject has an active infection - systemic or at the site of intended surgery
- Subject has a known allergy to any component of the devices used in the study
- Subject is pregnant or breast feeding
- Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Surgical Proficiency and Effectiveness of the Acumed(R) Scapholunate Repair System in Primary Scapholunate Instability Among Canadians
This study is a prospective, multi-centre, non-randomized, and non-blinded follow-up study to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction.
Read the detailed description
The scapholunate interosseous ligament (SLIL) of the wrist can be likened to the ACL of the knee as an often-injured ligament causing joint instability that frequently impairs function and requires surgical reconstruction. Yet wrist surgeons are significantly behind knee surgeons in their ability to achieve consistent and reliable outcomes with surgical reconstruction of this ligament. This ligament is often treated using a surgical procedure of reduction and association of scaphoid and lunate (RASL). However, this procedure is accompanied with technical challenges regarding proper screw placement and trajectory.
The ACUMED® Scapholunate Repair System presents as a novel and innovated device that has the potential to improve surgeon proficiency with the RASL procedure. The purpose of this trial is to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction. The study will assess the surgeon learning curve with the ACUMED® Scapholunate Repair System, record safety, complications, outcomes and adverse events for 2 years after surgery. This study will generate clinical evidence to support and maintain product registration in global markets.
Patients presenting with sub-acute or chronic (>8 weeks) primary SLIL instability that will be treated surgically at up to 20 study sites across Canada. A total of 50 wrists will be enrolled into the study and surgeons will utilize the ACUMED® Scapholunate Repair System during the surgical procedure. The study is expected to enroll all subjects within a 2-year time frame, and patients will be followed for 2 years after surgery. Subjects for whom the informed consent process has been completed and have been implanted with the study product will be considered enrolled.
At baseline, research staff will obtain data regarding participant demographics, injury characteristics, and medical history. Pre-operatively, participants will also be assessed for range of motion and grip strength and will have completed radiographs and three wrist function questionnaires, the DASH, the PRWE, and the PROMIS. Surgeons will answer questionnaires at the start of the study, after each surgical case, and at the end of the study to provide an assessment of the repair system's utility. The quality of screw placement will be graded on a newly created scale (from retrospective chart review of prior RASL procedures) to measure screw trajectory and final placement. Participants will have follow standard of care follow up timeline with preoperative visits at 2-, 8-, 12, 24- weeks, 1 year, 18 months, and 2 years. At each follow up visit, range of motion data, grip strength (after 24 weeks), and questionnaires will be completed.
Data will be reported as numbers and percentages of total for categorical data, and as mean and standard deviation of the mean with 95% confidence intervals for continuous variables. Ordinal data from the Likert scale surgeon questionnaire and screw placement grading scales will also be analyzed using parametric statistics (1, 2). Total scores from the scale items will be analyzed using the Kappa statistics. Independent sample t-tests will be used to compare the mean DASH, PRWE and PROMIS scores and for time to return to work, school, and sports. For secondary analysis, an analysis of variance will be completed for the DASH, PRWE and PROMIS scores, range of motion data and grip strength at each follow-up time interval.
- Being tested
- ACUMED® Scapholunate Repair System Group
- Keywords
- Scapholunate interosseous ligament, Reduction and association of the scaphoid and lunate, RASL, Acumed Scapholunate Repair System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUMED® Scapholunate Repair System GroupDevice
To address the technical difficulties associated with the RASL procedure, Dr. Mel Rosenwasser developed an external over-the-top jig that in theory enables accurate and easy scapholunate-axis screw placement. The Acumed Scapholunate Repair System was designed treat patients with acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability. This new Scapholunate Repair System features a targeting guide designed to enable the surgeon to reproducibly place the implant in optimal position. The implant allows physiologic intercarpal scapholunate rotation by means of a free rotation design. The procedure can forestall progressive osteoarthritis and the need for secondary salvage procedures.
| Study group | Role | What they receive |
|---|---|---|
| ACUMED® Scapholunate Repair System | Experimental | All participants in this trial will undergo the surgical RASL procedure using the ACUMED® Scapholunate Repair System. Receives: Device: ACUMED® Scapholunate Repair System Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess surgical proficiencies and effectiveness with the ACUMED® Scapholunate Repair System
Surgeons will complete a standardized proprietary questionnaire at the start of the study and on a case by case basis following each surgical procedure (Post-operatively). The goal is to measure and track the level of surgeon comfort and proficiency with the ACUMED® Scapholunate Repair System. Surgical time, tourniquet time and fluoroscopy time will be used a surrogate measures of surgical proficiency.
Measured: Immediately after surgery
Quality of Screw Placement
Scapholunate screw trajectory will be validated and graded based on screw angle (ideally 23 degrees), position in the ulnar vertex (proximal ulnar corner), and sagittal alignment (middle third of scaphoid) based on intra-operative or immediate post-operative AP and lateral X-rays.
Measured: Immediately after surgery
Secondary outcomes (2)
Correlate Clinical Outcomes to Reduction and Screw Trajectory
Functional outcomes will be assessed using the Patient-Rated Wrist Evaluation (PRWE), Disabilities of the Arm, Shoulder and Hand (DASH), PROMIS Upper Extremity, and Visual Analogue Pain Scale (VAS).
Measured: 2 years
Report Safety Complications and Adverse Events
Complications, adverse events and serious adverse events possibly related, probably related, or related to the device and/or the surgical procedure that may adversely affect study functional outcome scores will be recorded.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study startJan 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Complete Tear of Scapholunate LigamentStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multi-centre, non-randomized, and non-blinded follow-up study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Acumed, LLC
- Responsible party
- Principal investigator, Neil White, University of Calgary
- Investigators
- Neil J White, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980547
- Sponsor's protocol ID
- REB20-2245
- Acronym
- CanRASL
- Status last verified
- May 2022
- First submitted
- 15 Jul 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Geissler WB. Arthroscopically assisted reduction of intra-articular fractures of the distal radius. Hand Clin. 1995 Feb;11(1):19-29.
PubMed 7751327Messina JC, Van Overstraeten L, Luchetti R, Fairplay T, Mathoulin CL. The EWAS Classification of Scapholunate Tears: An Anatomical Arthroscopic Study. J Wrist Surg. 2013 May;2(2):105-9. doi: 10.1055/s-0033-1345265.
PubMed 24436801Montgomery SJ, Rollick NJ, Kubik JF, Meldrum AR, White NJ. Surgical outcomes of chronic isolated scapholunate interosseous ligament injuries: a systematic review of 805 wrists. Can J Surg. 2019 Mar 22;62(3):1-12. doi: 10.1503/cjs.006918. Online ahead of print.
PubMed 30900438
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Surgical Proficiency and Effectiveness of the Acumed(R) Scapholunate Repair System in Primary Scapholunate Instability Among Canadians
- ClinicalTrials.gov ID
- NCT04980547
- Acronym / sponsor ID
- CanRASL / REB20-2245
- Keywords
- Scapholunate interosseous ligament, Reduction and association of the scaphoid and lunate, RASL, Acumed Scapholunate Repair System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Acumed, LLC
- Study start
- Jan 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 Jul 2021 (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 prospective, multi-centre, non-randomized, and non-blinded follow-up study to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction.
Detailed description
The scapholunate interosseous ligament (SLIL) of the wrist can be likened to the ACL of the knee as an often-injured ligament causing joint instability that frequently impairs function and requires surgical reconstruction. Yet wrist surgeons are significantly behind knee surgeons in their ability to achieve consistent and reliable outcomes with surgical reconstruction of this ligament. This ligament is often treated using a surgical procedure of reduction and association of scaphoid and lunate (RASL). However, this procedure is accompanied with technical challenges regarding proper screw placement and trajectory.
The ACUMED® Scapholunate Repair System presents as a novel and innovated device that has the potential to improve surgeon proficiency with the RASL procedure. The purpose of this trial is to assess the efficacy and effectiveness of the ACUMED® Scapholunate Repair System in primary scapholunate interosseous ligament (SLIL) reconstruction. The study will assess the surgeon learning curve with the ACUMED® Scapholunate Repair System, record safety, complications, outcomes and adverse events for 2 years after surgery. This study will generate clinical evidence to support and maintain product registration in global markets.
Patients presenting with sub-acute or chronic (>8 weeks) primary SLIL instability that will be treated surgically at up to 20 study sites across Canada. A total of 50 wrists will be enrolled into the study and surgeons will utilize the ACUMED® Scapholunate Repair System during the surgical procedure. The study is expected to enroll all subjects within a 2-year time frame, and patients will be followed for 2 years after surgery. Subjects for whom the informed consent process has been completed and have been implanted with the study product will be considered enrolled.
At baseline, research staff will obtain data regarding participant demographics, injury characteristics, and medical history. Pre-operatively, participants will also be assessed for range of motion and grip strength and will have completed radiographs and three wrist function questionnaires, the DASH, the PRWE, and the PROMIS. Surgeons will answer questionnaires at the start of the study, after each surgical case, and at the end of the study to provide an assessment of the repair system's utility. The quality of screw placement will be graded on a newly created scale (from retrospective chart review of prior RASL procedures) to measure screw trajectory and final placement. Participants will have follow standard of care follow up timeline with preoperative visits at 2-, 8-, 12, 24- weeks, 1 year, 18 months, and 2 years. At each follow up visit, range of motion data, grip strength (after 24 weeks), and questionnaires will be completed.
Data will be reported as numbers and percentages of total for categorical data, and as mean and standard deviation of the mean with 95% confidence intervals for continuous variables. Ordinal data from the Likert scale surgeon questionnaire and screw placement grading scales will also be analyzed using parametric statistics (1, 2). Total scores from the scale items will be analyzed using the Kappa statistics. Independent sample t-tests will be used to compare the mean DASH, PRWE and PROMIS scores and for time to return to work, school, and sports. For secondary analysis, an analysis of variance will be completed for the DASH, PRWE and PROMIS scores, range of motion data and grip strength at each follow-up time interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multi-centre, non-randomized, and non-blinded follow-up study.
| Arm | Type | Receives |
|---|---|---|
| ACUMED® Scapholunate Repair System | Experimental | Device: ACUMED® Scapholunate Repair System GroupAll participants in this trial will undergo the surgical RASL procedure using the ACUMED® Scapholunate Repair System. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject has primary, chronic (> 6 weeks) scapholunate instability diagnosed by X-ray, dynamic X-ray, MRI/MRI arthrogram and/or arthroscopy
- Subject is a suitable candidate for RASL repair with the ACUMED® Scapholunate Repair System
- Subject is willing and able to participate in required follow-up visits and can complete study activities.
- Subject provides informed consent
Key exclusion criteria (12 listed)
- Subject has scapholunate advanced collapse wrist arthritis above grade I (styloid only)
- Subject has conditions that would eliminate or tend to eliminate adequate implant support:
- Subject has mental or neurological conditions which impair their ability or willingness to restrict activities that may put the affected limb at risk.
- Subject has physical conditions that tend to place extreme loads on the implants (Charcot joints, muscle deficiencies etc.).
- Subject has neuromuscular dysfunctions (paralysis, myolysis, etc.) which could cause instability of the wrist after surgery
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 |
|---|---|---|
| ACUMED® Scapholunate Repair System GroupTo address the technical difficulties associated with the RASL procedure, Dr. Mel Rosenwasser developed an external over-the-top jig that in theory enables accurate and easy scapholunate-axis screw placement. The Acumed Scapholunate Repair System was designed treat patients with acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability. This new Scapholunate Repair System features a targeting guide designed to enable the surgeon to reproducibly place the implant in optimal position. The implant allows physiologic intercarpal scapholunate rotation by means of a free rotation design. The procedure can forestall progressive osteoarthritis and the need for secondary salvage procedures. | Device | ACUMED® Scapholunate Repair System |
Primary outcome
Assess surgical proficiencies and effectiveness with the ACUMED® Scapholunate Repair System
Time frame: Immediately after surgery
Surgeons will complete a standardized proprietary questionnaire at the start of the study and on a case by case basis following each surgical procedure (Post-operatively). The goal is to measure and track the level of surgeon comfort and proficiency with the ACUMED® Scapholunate Repair System. Surgical time, tourniquet time and fluoroscopy time will be used a surrogate measures of surgical proficiency.
Quality of Screw Placement
Time frame: Immediately after surgery
Scapholunate screw trajectory will be validated and graded based on screw angle (ideally 23 degrees), position in the ulnar vertex (proximal ulnar corner), and sagittal alignment (middle third of scaphoid) based on intra-operative or immediate post-operative AP and lateral X-rays.
2 secondary outcomes
Correlate Clinical Outcomes to Reduction and Screw Trajectory
Time frame: 2 years
Report Safety Complications and Adverse Events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 7751327Geissler WB. Arthroscopically assisted reduction of intra-articular fractures of the distal radius. Hand Clin. 1995 Feb;11(1):19-29.
- Background: PubMed 24436801Messina JC, Van Overstraeten L, Luchetti R, Fairplay T, Mathoulin CL. The EWAS Classification of Scapholunate Tears: An Anatomical Arthroscopic Study. J Wrist Surg. 2013 May;2(2):105-9. doi: 10.1055/s-0033-1345265.
- Background: PubMed 30900438Montgomery SJ, Rollick NJ, Kubik JF, Meldrum AR, White NJ. Surgical outcomes of chronic isolated scapholunate interosseous ligament injuries: a systematic review of 805 wrists. Can J Surg. 2019 Mar 22;62(3):1-12. doi: 10.1503/cjs.006918. Online ahead of print.
- Link to Acumed description of investigational productLink provided by the sponsor.
- SCRUBS Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Neil J White, MD principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACUMED® Scapholunate Repair System Group in people with Complete Tear of Scapholunate Ligament and Scapholunate Dissociation, run by University of Calgary.
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 12 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 18 May 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Brenna Mattiello, BKin ((403)9563687, brenna.mattiello1@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess surgical proficiencies and effectiveness with the ACUMED® Scapholunate Repair System (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980547, which also lists 3 linked publications.
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 18 May 2022.