Non-Invasive Distractor During Knee Arthroscopy

NCT ID: NCT06458816

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Arthritis Knee Arthropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Medial Non-Invasive Knee Distraction

medial aspect of knee with distraction device

Group Type EXPERIMENTAL

Non-Invasive Knee Joint Distraction

Intervention Type DEVICE

Non-invasive Distraction device

Lateral Non-Invasive Knee Distraction

lateral aspect of knee with distraction device

Group Type EXPERIMENTAL

Non-Invasive Knee Joint Distraction

Intervention Type DEVICE

Non-invasive Distraction device

Medial Manual Knee Distraction

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

Group Type ACTIVE_COMPARATOR

Manual Joint Distraction

Intervention Type PROCEDURE

no device. manual distraction.

Lateral Manual Knee Distraction

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

Group Type ACTIVE_COMPARATOR

Manual Joint Distraction

Intervention Type PROCEDURE

no device. manual distraction.

Interventions

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Non-Invasive Knee Joint Distraction

Non-invasive Distraction device

Intervention Type DEVICE

Manual Joint Distraction

no device. manual distraction.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wilma Chan Highland Hospital Campus

UNKNOWN

Sponsor Role collaborator

The Taylor Collaboration

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward De Mayo, MD

Role: STUDY_DIRECTOR

Attending Orthopaedic Surgeon

Central Contacts

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Jamal Zahir, BS

Role: CONTACT

720-592-6202

Oluwatodimu R Raji, MEng

Role: CONTACT

510-570-7741

References

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

Reference Type BACKGROUND
PMID: 21765685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23703531 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20117632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12368784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26301179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32368461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17142441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32226748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25440203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31968005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27357272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25899684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22930834 (View on PubMed)

Related Links

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Other Identifiers

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SFORP 136

Identifier Type: -

Identifier Source: org_study_id

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