Ulnar/Radial Collateral Ligament ReconstructionNCT05046600
Registry of Arthrex Hand and Wrist Products
An observational study of Ulnar/Radial Collateral Ligament Reconstruction and Ligament Repair or Reconstruction, run by Arthrex, Inc. at 5 sites in United States.
Trial summary
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis
- What is being tested?
- Products listed in cohort description
- Type of treatment
- Medical device
- How many people
- 650 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Jul 2021to 1 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 50 subjects, male and female, 18 years of age or older will be enrolled for each product and material. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.
Who may be able to join
- Subject requires surgery using Arthrex hand and wrist implants included in the registry.
- Subject is 18 years of age or over.
- Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
- Subject signed informed consent and is willing and able to comply with all registry requirements
Who cannot join
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections, which may retard healing.
- Foreign-body sensitivity or foreign-body reactions.
- Any active infection or blood supply limitations.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
- Subjects that are skeletally immature -
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Jennifer Friend, Jennifer.Friend@duke.edu
Tyler Pidgeon, MD
- Terminated
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
West Virginia University
Morgantown, West Virginia, 26501
Faviola Aguilar-Burke, 304-598-4000, fa00016@hsc.wvu.edu
John Taras, MD
- Recruiting
MORE Foundation
Phoenix, Arizona, 85023
Damon Adamany, MD
- Recruiting
Banner Health
Tuscon, Arizona, 85006
Joshua Hustedt, MD, (520) 694-0111, marlenymunoz@arizona.edu
About this study
Official title: Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Read the detailed description
The objective of the registry is to evaluate the continued safety and effectiveness of the Arthrex hand and wrist products including the Biocomposite or PEEK PushLock® Anchors for ulnar/radial collateral ligament reconstruction; and/or the DX SwiveLock® SL Anchors (3.5 x 8.5mm) for ligament repair or reconstruction (e.g. scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction, and carpometacarpal joint arthroplasty); and/or, the Headless Compression Screws for small bone fragments; and/or, the arthrodesis Tenodesis Screw (Biocomposite and PEEK), for ulnar collateral ligament reconstruction; and/or, the Corkscrew® Titanium Anchor (Micro Corkscrew® Anchor) for ulnar/radial collateral ligament reconstruction, digital tendon transfers (Nano Corkscrew® Anchor); and/or, the DynaNite® Nitinol Staples for carpal fusion (arthrodesis) of the hand; and/or, the KreuLock™ Screws for Distal Radius
- Conditions
- Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis, Scapholunate Ligament Reconstruction, Carpal Fusion (Arthrodesis) of the Hand, Digital Tendon Transfers
- Being tested
- Products listed in cohort description
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Products listed in cohort descriptionDevice
Depending on approved indication per product
| Study group | Role | What they receive |
|---|---|---|
| All Products listed in Descriptions | Biocomposite™ or PEEK PushLock, DX SwiveLock SL, Headless Compression Screws, Tenodesis Screw (Biocomposite and PEEK), Corkscrew® Titanium (Nano and Micro-Corkscrew), DynaNite Nitinol Staples KreuLock Screws Receives: Device: Products listed in cohort description |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess a change in Visual Analogue Scale (VAS) survey
Patient reported pain scale 0-10 point scale (0 min,10 max)
Measured: Preoperatively, 3 months, 6 months and 12 months postoperatively
Secondary outcomes (1)
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Patient reported changes in general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring scores up
Measured: Preoperatively, 3 months, 6 months and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Jul 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulnar/Radial Collateral Ligament ReconstructionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046600
- Sponsor's protocol ID
- AIRR-0010
- Status last verified
- Jun 2025
- First submitted
- 31 Aug 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
- ClinicalTrials.gov ID
- NCT05046600
- Acronym / sponsor ID
- AIRR-0010
- Conditions
- Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction, Small Bone Fragments and Arthrodesis, Scapholunate Ligament Reconstruction, Carpal Fusion (Arthrodesis) of the Hand, Digital Tendon Transfers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 16 Sep 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.
A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Effectiveness of Hand and Wrist Products
Detailed description
The objective of the registry is to evaluate the continued safety and effectiveness of the Arthrex hand and wrist products including the Biocomposite or PEEK PushLock® Anchors for ulnar/radial collateral ligament reconstruction; and/or the DX SwiveLock® SL Anchors (3.5 x 8.5mm) for ligament repair or reconstruction (e.g. scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction, and carpometacarpal joint arthroplasty); and/or, the Headless Compression Screws for small bone fragments; and/or, the arthrodesis Tenodesis Screw (Biocomposite and PEEK), for ulnar collateral ligament reconstruction; and/or, the Corkscrew® Titanium Anchor (Micro Corkscrew® Anchor) for ulnar/radial collateral ligament reconstruction, digital tendon transfers (Nano Corkscrew® Anchor); and/or, the DynaNite® Nitinol Staples for carpal fusion (arthrodesis) of the hand; and/or, the KreuLock™ Screws for Distal Radius
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Products listed in Descriptions | – | Device: Products listed in cohort descriptionBiocomposite™ or PEEK PushLock, DX SwiveLock SL, Headless Compression Screws, Tenodesis Screw (Biocomposite and PEEK), Corkscrew® Titanium (Nano and Micro-Corkscrew), DynaNite Nitinol Staples KreuLock Screws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 subjects, male and female, 18 years of age or older will be enrolled for each product and material. Subjects will be recruited from the surgeon's patient population or referrals from other physicians.
Key inclusion criteria (4 listed)
- Subject requires surgery using Arthrex hand and wrist implants included in the registry.
- Subject is 18 years of age or over.
- Subject is not considered a vulnerable subject (i.e. child, pregnant, nursing, prisoner, or ward of the state).
- Subject signed informed consent and is willing and able to comply with all registry requirements
Key exclusion criteria (6 listed)
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections, which may retard healing.
- Foreign-body sensitivity or foreign-body reactions.
- Any active infection or blood supply limitations.
- Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
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 |
|---|---|---|
| Products listed in cohort descriptionDepending on approved indication per product | Device | All Products listed in Descriptions |
Primary outcome
To assess a change in Visual Analogue Scale (VAS) survey
Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Patient reported pain scale 0-10 point scale (0 min,10 max)
1 secondary outcome
To assess a change in Veterans Rand 12-Item Health Survey (VR-12)
Time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulnar/Radial Collateral Ligament Reconstruction and Ligament Repair or Reconstruction, run by Arthrex, Inc. at 5 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin F Moss, DHSc,CCRP (7705844972, justin.moss@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess a change in Visual Analogue Scale (VAS) survey (time frame: Preoperatively, 3 months, 6 months and 12 months postoperatively). 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 26 Jun 2025.