ACL InjuryNCT04689061
FastThread Interference Screws
An observational study of ACL Injury, run by Arthrex, Inc. at 2 sites in 2 countries.
Trial summary
Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Injury
- What is being tested?
- Arthrex FastThread Interference Screw
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Aug 2020to Aug 2023
- How long will I take part?
- 12 Months
- 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: Approximately 50 subjects, male and female, at least 18 years of age, will be enrolled for the study. Subjects will be recruited from the surgeon's patient population or referrals from other physicians. The enrollment period is estimated to be 12 months.
Who may be able to join
- Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCL at US sites only) repair or reconstruction or the Arthrex Biocomposite Interference Screw for PCL (PCL at US sites only) repair or reconstruction.
- 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 study requirements.
Who cannot join
- Current bilateral injury of the ACL or PCL.
- Injury of the ACL and PCL in the same knee.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Foreign-body sensitivity.
- 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
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Anderson Sports Medicine
Bingham Farms, Michigan, 48025
Samantha Martino, 800-933-7001 ext. 73506, samantha.martino@arthrex.com
Germany1 site, 1 recruiting
- Recruiting
Sportklinik Ravensburg
Ravensburg, 88214
Sarah Villinger, +49(89)9099005 ext. 4231, sarah.villinger@arthrex.de
About this study
Official title: A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws
Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.
Read the detailed description
The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only).
To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality.
- Conditions
- ACL Injury
- Being tested
- Arthrex FastThread Interference Screw
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrex FastThread Interference ScrewDevice
The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping. The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping
| Study group | Role | What they receive |
|---|---|---|
| Biocomposite FastThread Interference Screw | The absorbable Biocomposite Interference Screws combine the inherent degradation characteristics of a biocompatible polymer with the bioactivity of a ceramic. They are made of a combination of 70% poly (L-lactide-co-D, L-lactide) (PLDLA) and 30% biphasic calcium phosphate (BCP). The material has withstood the test of time with over a decade of clinical use and millions of implantations. It has been shown that the Biocomposite Interference Screw integrates well into the surrounding bone, produces little to no inflammatory response, and partially degrades 2 years after implantation Receives: Device: Arthrex FastThread Interference Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess change in Visual Analogue Scale (VAS)
Patient reported pain scale 0-10 point scale (0 min, 10 max)
Measured: preoperatively, 3 months, 6 months and 12 months post operative
To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient reported outcome assessment. The interval score ranges from 0 to 100, (where 0 represents total knee disability and 100 represents perfect knee health)
Measured: preoperatively, 3 months, 6 months and 12 months post operative
To assess change in Range of Motion (ROM)
Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees
Measured: preoperatively, 3 months, 6 months and 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start31 Aug 2020
- Primary completionFeb 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arthrex GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689061
- Sponsor's protocol ID
- AIRR-0011
- Status last verified
- Feb 2022
- First submitted
- 23 Dec 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Study to Evaluate the Continued Safety and Effectiveness of the FastThread Interference Screws
- ClinicalTrials.gov ID
- NCT04689061
- Acronym / sponsor ID
- AIRR-0011
- Conditions
- ACL Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Arthrex GmbH
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 30 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.
Surgery using the Arthrex PEEK or Biocomposite FastThread Interference Screw for ACL or PCL (PCL at US sites only, Biocomposite screw PCL only) repair or reconstruction.
Detailed description
The objective of the study is to evaluate the continued safety and effectiveness of the PEEK and Biocomposite FastThread Interference Screws used for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) repair or reconstruction (PCL at US sites only, Biocomposite screw PCL only).
To assess safety, device-related adverse events will be reported and evaluated over the course of the study. To evaluate effectiveness, patient reported outcomes will be collected at 3 months postoperative, 6 months postoperative, and one year postoperative using the Visual Analogue Scale (VAS) for measuring pain in the affected knee and the Knee Injury and Osteoarthritis Outcome Score (KOOS) as well as Range of Motion (ROM, optional) for measuring knee functionality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biocomposite FastThread Interference Screw | – | Device: Arthrex FastThread Interference ScrewThe absorbable Biocomposite Interference Screws combine the inherent degradation characteristics of a biocompatible polymer with the bioactivity of a ceramic. They are made of a combination of 70% poly (L-lactide-co-D, L-lactide) (PLDLA) and 30% biphasic calcium phosphate (BCP). The material has withstood the test of time with over a decade of clinical use and millions of implantations. It has been shown that the Biocomposite Interference Screw integrates well into the surrounding bone, produces little to no inflammatory response, and partially degrades 2 years after implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 subjects, male and female, at least 18 years of age, will be enrolled for the study. Subjects will be recruited from the surgeon's patient population or referrals from other physicians. The enrollment period is estimated to be 12 months.
Key inclusion criteria (4 listed)
- Subject requires surgery using the Arthrex PEEK Interference Screw for ACL or PCL (PCL at US sites only) repair or reconstruction or the Arthrex Biocomposite Interference Screw for PCL (PCL at US sites only) repair or reconstruction.
- 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 study requirements.
Key exclusion criteria (8 listed)
- Current bilateral injury of the ACL or PCL.
- Injury of the ACL and PCL in the same knee.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Foreign-body sensitivity.
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 |
|---|---|---|
| Arthrex FastThread Interference ScrewThe Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping. The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping | Device | Biocomposite FastThread Interference Screw |
Primary outcome
To assess change in Visual Analogue Scale (VAS)
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported pain scale 0-10 point scale (0 min, 10 max)
To assess change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Patient reported outcome assessment. The interval score ranges from 0 to 100, (where 0 represents total knee disability and 100 represents perfect knee health)
To assess change in Range of Motion (ROM)
Time frame: preoperatively, 3 months, 6 months and 12 months post operative
Measuring knee functionality. (Flexion 0 to 130 degrees Extension 120 to 0 degrees
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury, run by Arthrex, Inc. at 2 sites in 2 countries.
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 8 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 16 Feb 2022. 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, Germany. 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 Samantha Martino (800.933.7001 ext. 73506, samantha.martino@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess change in Visual Analogue Scale (VAS) (time frame: preoperatively, 3 months, 6 months and 12 months post operative). The study lists 3 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 16 Feb 2022.