Non-Invasive Distractor During Knee Arthroscopy

NCT06458816 | Not Yet Recruiting FDA Device

• 1 other identifier: SFORP 136
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Arthritis; Knee Arthropathy

Keywords

arthroscopy; knee joint distraction; non invasive; sports medicine

Outcome Measures

Primary Outcomes (2)

• Medial Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe

  with manual distraction vs non-invasive distractor

  intraoperative

• Lateral Knee Joint Distraction Distance measured in millimeters (mm) during arthroscopy using a reference probe

  with manual distraction vs non-invasive distractor

  intraoperative

Secondary Outcomes (1)

• Pre and Post operative pain scores

  preoperative and within 1 year after knee arthroscopy

Study Arms (4)

Medial Non-Invasive Knee Distraction

EXPERIMENTAL

medial aspect of knee with distraction device

Device: Non-Invasive Knee Joint Distraction

Lateral Non-Invasive Knee Distraction

EXPERIMENTAL

lateral aspect of knee with distraction device

Device: Non-Invasive Knee Joint Distraction

Medial Manual Knee Distraction

ACTIVE COMPARATOR

medial aspect of knee with only manual distraction. no device.

Procedure: Manual Joint Distraction

Lateral Manual Knee Distraction

ACTIVE COMPARATOR

lateral aspect of knee with only manual distraction. no device.

Procedure: Manual Joint Distraction

Interventions

Non-Invasive Knee Joint Distraction DEVICE

Non-invasive Distraction device

Lateral Non-Invasive Knee Distraction; Medial Non-Invasive Knee Distraction

Manual Joint Distraction PROCEDURE

no device. manual distraction.

Lateral Manual Knee Distraction; Medial Manual Knee Distraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Taylor Collaboration: lead
• Wilma Chan Highland Hospital Campus: collaborator

Related Publications (13)

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

  PMID: 21765685 BACKGROUND

• 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.

  PMID: 23703531 BACKGROUND

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

  PMID: 20117632 BACKGROUND

• 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.

  PMID: 12368784 BACKGROUND

• 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.

  PMID: 26301179 BACKGROUND

• 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.

  PMID: 32368461 BACKGROUND

• 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.

  PMID: 17142441 BACKGROUND

• 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.

  PMID: 32226748 BACKGROUND

• 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.

  PMID: 25440203 BACKGROUND

• 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.

  PMID: 31968005 BACKGROUND

• 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.

  PMID: 27357272 BACKGROUND

• 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.

  PMID: 25899684 BACKGROUND

• 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.

  PMID: 22930834 BACKGROUND

Related Links

• Related Info

Study Officials

• Edward De Mayo, MD

  Attending Orthopaedic Surgeon

  STUDY DIRECTOR

Central Study Contacts

Jamal Zahir, BS

CONTACT

720-592-6202; jzahir@taylorcollaboration.org

Oluwatodimu R Raji, MEng

CONTACT

510-570-7741; rraji@taylorcollaboration.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share