Anterior Cruciate LigamentNCT07553975
Randomized Arthrex Nano Arthroscopy in Arthroscopic ACL vs Conventional Arthroscopy
A study testing ACL surgery using Arthrex NanoScope and ACL surgery using conventional arthroscopy in people with Anterior Cruciate Ligament, run by University of Colorado, Denver.
Trial summary
The study is a pilot study designed to generate preliminary data regarding the cost of ACL surgery using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament
- What is being tested?
- ACL surgery using Arthrex NanoScope and ACL surgery using conventional arthroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is 18 - 60 years of age.
- Subject body mass index (BMI) is 40 or lower (BMI ≤ 40).
- Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- Confirmed ACL injury by MRI and physical exam as per standard of care.
- Subjects not excluded for having meniscal pathology that requires resection or repair.
- Subjects not excluded for having lateral-extra-articular tenodesis
Who cannot join
- Revision ACL case.
- Current bilateral knee injury.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Subjects that are skeletally immature.
- Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
Show all 13Show fewer
- Fracture of the lower extremities within 6 months prior to screening.
- Previous surgery on the affected knee within 12 months related to the ACL reconstruction, prior to screening.
- Sensitivity to silicone, polyester, nylon, FD\&C Blue No. 2 dye and beeswax.
- Other concomitant disease that would interfere with study outcomes.
- Subject is included in a vulnerable population (child, prisoner, etc.).
- Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
- Subject is requesting or receiving Worker's compensation related to the knee injury.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hana Durkee contact
About this study
Official title: Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee ACL Surgery Versus Conventional Arthroscopy
The study is a pilot study designed to generate preliminary data regarding the cost of ACL surgery using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting.
- Conditions
- Anterior Cruciate Ligament
- Being tested
- ACL surgery using Arthrex NanoScope, ACL surgery using conventional arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL surgery using Arthrex NanoScopeDevice
The rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions.
ACL surgery using conventional arthroscopyProcedure or surgery
Conventional arthroscopy using standard of care equipment
| Study group | Role | What they receive |
|---|---|---|
| ACL surgery using Arthrex NanoScope | Experimental | The rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions. Receives: Device: ACL surgery using Arthrex NanoScope |
| ACL surgery using conventional arthroscopy | Active comparator | Conventional arthroscopy using standard of care equipment Receives: Procedure: ACL surgery using conventional arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
- Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
- Patient Reported Outcomes Visual Analog Scale (VAS)
Measured: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
- Patient Reported Outcomes Single Assessment Numeric Evaluation (SANE)
Measured: From enrollment to 2years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
- Patient Reported Outcomes International Knee Documentation Committee Subjective Measure (IKDC)
Measured: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
- Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a scale
Measured: From enrollment to 2 years
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
- Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6a scale
Measured: From enrollment to 2 years
Secondary outcomes (7)
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics Surgical Time, Units: Minutes
Measured: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics Tourniquet Time, Units: Minutes
Measured: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics Fluid Utilized, Units: milliliters
Measured: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics Anesthetic Type Used: general, local, or regional
Measured: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics Anesthetic Amount Used: Minutes, milliliters
Measured: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics OR Turnover Time, Units: minutes
Measured: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
- OR Metrics Cost (nanoscope 2.0 versus conventional arthroscopy), Units: US Dollars
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- Rachel M Frank, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553975
- Sponsor's protocol ID
- 25-2232
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Evaluating Cost of Arthrex Nano Arthroscopy Products in Arthroscopic Knee ACL Surgery Versus Conventional Arthroscopy
- ClinicalTrials.gov ID
- NCT07553975
- Acronym / sponsor ID
- 25-2232
- Conditions
- Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 28 Apr 2026 (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.
The study is a pilot study designed to generate preliminary data regarding the cost of ACL surgery using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL surgery using Arthrex NanoScope | Experimental | Device: ACL surgery using Arthrex NanoScopeThe rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions. |
| ACL surgery using conventional arthroscopy | Active comparator | Procedure: ACL surgery using conventional arthroscopyConventional arthroscopy using standard of care equipment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is 18 - 60 years of age.
- Subject body mass index (BMI) is 40 or lower (BMI ≤ 40).
- Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
- Confirmed ACL injury by MRI and physical exam as per standard of care.
- Subjects not excluded for having meniscal pathology that requires resection or repair.
Key exclusion criteria (13 listed)
- Revision ACL case.
- Current bilateral knee injury.
- Insufficient quantity or quality of bone.
- Blood supply limitations and previous infections which may retard healing.
- Subjects that are skeletally immature.
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 |
|---|---|---|
| ACL surgery using Arthrex NanoScopeThe rod-lens arthroscope has been the standard of care in the operating room for more than 40 years. Arthrex's all-in-one disposable, 2 mm, chip-on-tip camera system now allows surgeons to miniaturize their treatment solutions. | Device | ACL surgery using Arthrex NanoScope |
| ACL surgery using conventional arthroscopyConventional arthroscopy using standard of care equipment | Procedure or surgery | ACL surgery using conventional arthroscopy |
Primary outcome
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
Time frame: From enrollment to 2 years
1. Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score (KOOS)
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
Time frame: From enrollment to 2 years
2. Patient Reported Outcomes Visual Analog Scale (VAS)
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
Time frame: From enrollment to 2years
3. Patient Reported Outcomes Single Assessment Numeric Evaluation (SANE)
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
Time frame: From enrollment to 2 years
4. Patient Reported Outcomes International Knee Documentation Committee Subjective Measure (IKDC)
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
Time frame: From enrollment to 2 years
5. Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a scale
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy.
Time frame: From enrollment to 2 years
6. Patient Reported Outcomes Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6a scale
7 secondary outcomes
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: immediately postoperatively
Operating Room (OR) metrics that may be correlated with staff satisfaction and operating team satisfaction.
Time frame: 1 month 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 28 Apr 2026.
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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.
Hana Durkee contact
Rachel M Frank, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing ACL surgery using Arthrex NanoScope and ACL surgery using conventional arthroscopy in people with Anterior Cruciate Ligament, run by University of Colorado, Denver.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 28 Apr 2026. 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?
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 Gregory Ottenberg (303-724-6538, GREGORY.OTTENBERG@CUANSCHUTZ.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare patient satisfaction for Anterior Cruciate Ligament (ACL) surgery when using either Arthrex Nanoscope 2.0 or conventional arthroscopy. (time frame: From enrollment to 2 years). The study lists 6 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 28 Apr 2026.