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NCT06458816 Clinical Trial

Non-Invasive Distractor During Knee Arthroscopy

Knee Arthritis Clinical Trial

Official title:
The Utility of a Non-Invasive Distractor During Arthroscopy of the Knee Joint

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06458816
Other study ID # SFORP 136
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date January 2025

Study information
Verified date June 2024
Source The Taylor Collaboration
Contact Jamal Zahir, BS
Phone 720-592-6202
Email jzahir@taylorcollaboration.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 14
Est. completion date January 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Non-Invasive Knee Joint Distraction
Non-invasive Distraction device
Procedure:
• Manual Joint Distraction
no device. manual distraction.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
The Taylor Collaboration Wilma Chan Highland Hospital Campus

References & Publications (13)

DeMaio 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. — View Citation

Dienst 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. — View Citation

Jackson RW. A history of arthroscopy. Arthroscopy. 2010 Jan;26(1):91-103. doi: 10.1016/j.arthro.2009.10.005. No abstract available. — View Citation

Jansen 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. — View Citation

Khademi-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. — View Citation

Kramer 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. — View Citation

Lee 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. — View Citation

Moran 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. — View Citation

Ohishi 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. — View Citation

Rovesti 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. — View Citation

Schneider 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. — View Citation

Treuting R. Minimally invasive orthopedic surgery: arthroscopy. Ochsner J. 2000 Jul;2(3):158-63. — View Citation

Winkels 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe with manual distraction vs non-invasive distractor intraoperative
Primary Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe with manual distraction vs non-invasive distractor intraoperative
Secondary Pre and Post operative pain scores VAS preoperative and within 1 year after knee arthroscopy
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