Knee ArthritisNCT06458816
Non-Invasive Distractor During Knee Arthroscopy
A study testing Non-Invasive Knee Joint Distraction and Manual Joint Distraction in people with Knee Arthritis and Knee Arthropathy, run by The Taylor Collaboration.
Trial summary
Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis, Knee Arthropathy
- What is being tested?
- Non-Invasive Knee Joint Distraction and Manual Joint Distraction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jan 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age who have capacity to provide informed consent. Eligible participants will include existing patients of Dr. DiStefano who are scheduled to undergo knee arthroscopic surgery to address meniscal pathology. Study risks, benefits and description will be provided and informed consent will be obtained.
Who cannot join
- Patients with prior history of neurovascular deficiency or history of prior injury
- Patients with a prior history of knee surgery
- Patients with diagnosed knee ligament laxity or knee instability.
- Patients that are not cleared for knee arthroscopy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Utility of a Non-Invasive Distractor During Arthroscopy of the Knee Joint
Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Intraoperative arthroscopic images will be evaluated by the attending Orthopaedic surgeon with standard and testing mechanism and a measuring device will be used to measure the distance between the femur and tibia in the medial and lateral compartments.
- Conditions
- Knee Arthritis, Knee Arthropathy
- Being tested
- Non-Invasive Knee Joint Distraction, Manual Joint Distraction
- Keywords
- arthroscopy, knee joint distraction, non invasive, sports medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Knee Joint DistractionDevice
Non-invasive Distraction device
Manual Joint DistractionProcedure or surgery
no device. manual distraction.
| Study group | Role | What they receive |
|---|---|---|
| Medial Non-Invasive Knee Distraction | Experimental | medial aspect of knee with distraction device Receives: Device: Non-Invasive Knee Joint Distraction |
| Lateral Non-Invasive Knee Distraction | Experimental | lateral aspect of knee with distraction device Receives: Device: Non-Invasive Knee Joint Distraction |
| Medial Manual Knee Distraction | Active comparator | medial aspect of knee with only manual distraction. no device. Receives: Procedure: Manual Joint Distraction |
| Lateral Manual Knee Distraction | Active comparator | lateral aspect of knee with only manual distraction. no device. Receives: Procedure: Manual Joint Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
with manual distraction vs non-invasive distractor
Measured: intraoperative
Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
with manual distraction vs non-invasive distractor
Measured: intraoperative
Secondary outcomes (1)
Pre and Post operative pain scores
VAS
Measured: preoperative and within 1 year after knee arthroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Knee ArthritisStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a prospective cohort study the utility of a non-invasive distractor during arthroscopy. We hypothesize that the non-invasive distractor in conjunction with the DeMayo leg holder will provide superior medial and lateral compartment distraction with greater stability of the operative leg compared to standard manual arthroscopy techniques.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Taylor Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Wilma Chan Highland Hospital Campus
- Responsible party
- Sponsor
- Investigators
- Edward De Mayo, MD, Study director, Attending Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458816
- Sponsor's protocol ID
- SFORP 136
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Treuting R. Minimally invasive orthopedic surgery: arthroscopy. Ochsner J. 2000 Jul;2(3):158-63.
PubMed 21765685DeMaio M. Giants of orthopaedic surgery: Masaki Watanabe MD. Clin Orthop Relat Res. 2013 Aug;471(8):2443-8. doi: 10.1007/s11999-013-3052-1. Epub 2013 May 24. No abstract available.
PubMed 23703531Jackson RW. A history of arthroscopy. Arthroscopy. 2010 Jan;26(1):91-103. doi: 10.1016/j.arthro.2009.10.005. No abstract available.
PubMed 20117632Dienst M, Seil R, Godde S, Brang M, Becker K, Georg T, Kohn D. Effects of traction, distension, and joint position on distraction of the hip joint: an experimental study in cadavers. Arthroscopy. 2002 Oct;18(8):865-71. doi: 10.1053/jars.2002.36120.
PubMed 12368784Ohishi T, Takahashi M, Suzuki D, Matsuyama Y. Arthroscopic approach to the posterior compartment of the knee using a posterior transseptal portal. World J Orthop. 2015 Aug 18;6(7):505-12. doi: 10.5312/wjo.v6.i7.505. eCollection 2015 Aug 18.
PubMed 26301179Lee JY, Chia ZY, Jiang L, Ang B, Chang P. A Review of the Gillquist Maneuver: Modifications for a Safer and Easily Reproducible Approach for Knee Transintercondylar Notch Posterior Compartment Arthroscopy. Arthrosc Tech. 2020 Mar 3;9(4):e435-e438. doi: 10.1016/j.eats.2019.11.014. eCollection 2020 Apr.
PubMed 32368461Kramer DE, Bahk MS, Cascio BM, Cosgarea AJ. Posterior knee arthroscopy: anatomy, technique, application. J Bone Joint Surg Am. 2006 Dec;88 Suppl 4:110-21. doi: 10.2106/JBJS.F.00607. No abstract available.
PubMed 17142441Moran TE, Demers A, Awowale JT, Werner BC, Miller MD. The Outside-In, Percutaneous Release of the Medial Collateral Ligament for Knee Arthroscopy. Arthrosc Tech. 2020 Feb 25;9(3):e393-e397. doi: 10.1016/j.eats.2019.11.008. eCollection 2020 Mar.
PubMed 32226748Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11.
PubMed 25440203Jansen MP, Mastbergen SC, van Heerwaarden RJ, Spruijt S, van Empelen MD, Kester EC, Lafeber FPJG, Custers RJH. Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data. PLoS One. 2020 Jan 22;15(1):e0227975. doi: 10.1371/journal.pone.0227975. eCollection 2020.
PubMed 31968005Winkels P, Pozzi A, Cook R, Bottcher P. Prospective Evaluation of the Leipzig Stifle Distractor. Vet Surg. 2016 Jul;45(5):631-5. doi: 10.1111/vsu.12495.
PubMed 27357272Rovesti GL, Devesa-Garcia V, Urrutia PG, San Roman F, Rodriguez-Quiros J. Evaluation of a distractor to increase joint space of the stifle joint in dogs: a cadaveric study. Vet Comp Orthop Traumatol. 2015;28(3):179-85. doi: 10.3415/VCOT-14-04-0058. Epub 2015 Apr 22.
PubMed 25899684Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. doi: 10.1038/nmeth.2089.
PubMed 22930834
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of a Non-Invasive Distractor During Arthroscopy of the Knee Joint
- ClinicalTrials.gov ID
- NCT06458816
- Acronym / sponsor ID
- SFORP 136
- Conditions
- Knee Arthritis, Knee Arthropathy
- Keywords
- arthroscopy, knee joint distraction, non invasive, sports medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The Taylor CollaborationUniversity, hospital or other
- Collaborators
- Wilma Chan Highland Hospital Campus
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Jun 2024 (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.
Patients will be prospectively recruited for knee joint distraction who are undergoing knee arthroscopy. Patient demographics, operative factors, and rates of medical comorbidities will be collected and evaluated. Intraoperative arthroscopic images will be evaluated by the attending Orthopaedic surgeon with standard and testing mechanism and a measuring device will be used to measure the distance between the femur and tibia in the medial and lateral compartments.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a prospective cohort study the utility of a non-invasive distractor during arthroscopy. We hypothesize that the non-invasive distractor in conjunction with the DeMayo leg holder will provide superior medial and lateral compartment distraction with greater stability of the operative leg compared to standard manual arthroscopy techniques.
| Arm | Type | Receives |
|---|---|---|
| Medial Non-Invasive Knee Distraction | Experimental | Device: Non-Invasive Knee Joint Distractionmedial aspect of knee with distraction device |
| Lateral Non-Invasive Knee Distraction | Experimental | Device: Non-Invasive Knee Joint Distractionlateral aspect of knee with distraction device |
| Medial Manual Knee Distraction | Active comparator | Procedure: Manual Joint Distractionmedial aspect of knee with only manual distraction. no device. |
| Lateral Manual Knee Distraction | Active comparator | Procedure: Manual Joint Distractionlateral aspect of knee with only manual distraction. no device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ≥ 18 years of age who have capacity to provide informed consent. Eligible participants will include existing patients of Dr. DiStefano who are scheduled to undergo knee arthroscopic surgery to address meniscal pathology. Study risks, benefits and description will be provided and informed consent will be obtained.
Key exclusion criteria (4 listed)
- Patients with prior history of neurovascular deficiency or history of prior injury
- Patients with a prior history of knee surgery
- Patients with diagnosed knee ligament laxity or knee instability.
- Patients that are not cleared for knee arthroscopy
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 |
|---|---|---|
| Non-Invasive Knee Joint DistractionNon-invasive Distraction device | Device | Lateral Non-Invasive Knee Distraction, Medial Non-Invasive Knee Distraction |
| Manual Joint Distractionno device. manual distraction. | Procedure or surgery | Lateral Manual Knee Distraction, Medial Manual Knee Distraction |
Primary outcome
Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
Time frame: intraoperative
with manual distraction vs non-invasive distractor
Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe
Time frame: intraoperative
with manual distraction vs non-invasive distractor
1 secondary outcome
Pre and Post operative pain scores
Time frame: preoperative and within 1 year after knee arthroscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 21765685Treuting R. Minimally invasive orthopedic surgery: arthroscopy. Ochsner J. 2000 Jul;2(3):158-63.
- Background: PubMed 23703531DeMaio M. Giants of orthopaedic surgery: Masaki Watanabe MD. Clin Orthop Relat Res. 2013 Aug;471(8):2443-8. doi: 10.1007/s11999-013-3052-1. Epub 2013 May 24. No abstract available.
- Background: PubMed 20117632Jackson RW. A history of arthroscopy. Arthroscopy. 2010 Jan;26(1):91-103. doi: 10.1016/j.arthro.2009.10.005. No abstract available.
- Background: PubMed 12368784Dienst M, Seil R, Godde S, Brang M, Becker K, Georg T, Kohn D. Effects of traction, distension, and joint position on distraction of the hip joint: an experimental study in cadavers. Arthroscopy. 2002 Oct;18(8):865-71. doi: 10.1053/jars.2002.36120.
- Background: PubMed 26301179Ohishi T, Takahashi M, Suzuki D, Matsuyama Y. Arthroscopic approach to the posterior compartment of the knee using a posterior transseptal portal. World J Orthop. 2015 Aug 18;6(7):505-12. doi: 10.5312/wjo.v6.i7.505. eCollection 2015 Aug 18.
- Background: PubMed 32368461Lee JY, Chia ZY, Jiang L, Ang B, Chang P. A Review of the Gillquist Maneuver: Modifications for a Safer and Easily Reproducible Approach for Knee Transintercondylar Notch Posterior Compartment Arthroscopy. Arthrosc Tech. 2020 Mar 3;9(4):e435-e438. doi: 10.1016/j.eats.2019.11.014. eCollection 2020 Apr.
- Background: PubMed 17142441Kramer DE, Bahk MS, Cascio BM, Cosgarea AJ. Posterior knee arthroscopy: anatomy, technique, application. J Bone Joint Surg Am. 2006 Dec;88 Suppl 4:110-21. doi: 10.2106/JBJS.F.00607. No abstract available.
- Background: PubMed 32226748Moran TE, Demers A, Awowale JT, Werner BC, Miller MD. The Outside-In, Percutaneous Release of the Medial Collateral Ligament for Knee Arthroscopy. Arthrosc Tech. 2020 Feb 25;9(3):e393-e397. doi: 10.1016/j.eats.2019.11.008. eCollection 2020 Mar.
- Background: PubMed 25440203Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11.
- Background: PubMed 31968005Jansen MP, Mastbergen SC, van Heerwaarden RJ, Spruijt S, van Empelen MD, Kester EC, Lafeber FPJG, Custers RJH. Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data. PLoS One. 2020 Jan 22;15(1):e0227975. doi: 10.1371/journal.pone.0227975. eCollection 2020.
- Background: PubMed 27357272Winkels P, Pozzi A, Cook R, Bottcher P. Prospective Evaluation of the Leipzig Stifle Distractor. Vet Surg. 2016 Jul;45(5):631-5. doi: 10.1111/vsu.12495.
- Background: PubMed 25899684Rovesti GL, Devesa-Garcia V, Urrutia PG, San Roman F, Rodriguez-Quiros J. Evaluation of a distractor to increase joint space of the stifle joint in dogs: a cadaveric study. Vet Comp Orthop Traumatol. 2015;28(3):179-85. doi: 10.3415/VCOT-14-04-0058. Epub 2015 Apr 22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Edward De Mayo, MD study director
Attending Orthopaedic Surgeon
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Knee Joint Distraction and Manual Joint Distraction in people with Knee Arthritis and Knee Arthropathy, run by The Taylor Collaboration.
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 1 inclusion and 4 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 14 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamal Zahir, BS (720-592-6202, jzahir@taylorcollaboration.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe (time frame: intraoperative). 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 NCT06458816, which also lists 13 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 14 Jun 2024.