Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

NCT02648971 | Terminated Results

• 1 other identifier: IRB00030774
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled clinical trial will compare the outcomes of single portal versus two portal techniques in patients who have meniscus or articular cartilage pathology. The study hypothesis is that patients who undergo single portal arthroscopy will have less pain post-operatively, use less pain medication, and have a higher International Knee Documentation Committee (IKDC) score at six months and one year compared to patients who undergo traditional two portal knee arthroscopy.

Conditions

Injuries, Knee

Keywords

knee; arthroscopy; portal; meniscus; cartilage injury

Outcome Measures

Primary Outcomes (5)

• IKDC (International Knee Documentation Committee) Score

  IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  Baseline

• IKDC Score

  IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  30 days

• IKDC Score

  IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  3 Months

• IKDC Score

  IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  6 Months

• IKDC Score

  IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  12 Months

Secondary Outcomes (3)

• Pain Levels

  Days 1 and 4

• Number of Participants That Required the Use of Pain Medication

  Days 1 and 4

• Number of Participants That Required the Use of Narcotics

  Days 1 and 4

Study Arms (2)

Single Portal Knee Arthroscopy

ACTIVE COMPARATOR

After randomization for each patient is complete, the website will document the name of the person who logged on to perform the randomization, the date and time of the log in, and the surgical group assignment for each patient. This randomization information will be forwarded to the operating room staff so that they can prepare for each study participant's surgical procedure. Patients in Group 1 will undergo knee arthroscopy using a single portal. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.

Procedure: Single Portal Knee Arthroscopy

Two Portal Knee Arthroscopy

ACTIVE COMPARATOR

Patients in Group 2 will undergo knee arthroscopy using two portals. The details of the surgical procedure for each study participant will be documented on the IKDC Surgical Documentation Form. Study participants in each group will return for standard post-operative follow-up visits at one week, 30 days, and three months. They will return to the clinic at six months and one year for study visits.

Procedure: Two Portal Knee Arthroscopy

Interventions

Single Portal Knee Arthroscopy PROCEDURE

Patients in Group 1 will undergo knee arthroscopy using a single portal.

Single Portal Knee Arthroscopy

Two Portal Knee Arthroscopy PROCEDURE

Patients in Group 2 will undergo knee arthroscopy using two portals.

Two Portal Knee Arthroscopy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 21 and 65 years of age, who agree to comply with the protocol
• Patients undergoing a primary knee arthroscopy procedure for meniscus or articular cartilage pathology

You may not qualify if:

• Patients with a history of long term pain medication use and/or chronic pain conditions unrelated to the surgery.
• Subjects with severe renal disease, allergies to pain medication, and subjects that will have adverse drug-drug reactions from prescribed pain medication.
• Patients with previous reconstructive procedures, lateral retinacular release, or microfracture
• Active knee infection or sepsis at the time of surgery
• Meniscal injuries requiring repair
• Ligamentous instability
• Advanced degenerative or inflammatory arthritis
• Known cancer at the time of surgery
• Conditions that might interfere with recovery from knee arthroscopy (i.e. conditions or diseases of the nervous and/or muscular system, vascular disease, uncontrolled diabetes)
• Malignant tumor history or treatment of malignant tumor of the knee
• Lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture, knee arthrofibrosis)
• Pregnant, breast feeding, or planning on becoming pregnant during the time frame of the study, (if a woman of child-bearing age)
• Emotional or neurological conditions that affect the subject's ability or willingness to participate in the study including mental illness or drug and/or alcohol abuse
• Severely overweight (BMI \>40) at study enrollment or surgery
• Currently participating in another research study

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

• Irrgang JJ, Anderson AF, Boland AL, Harner CD, Kurosaka M, Neyret P, Richmond JC, Shelborne KD. Development and validation of the international knee documentation committee subjective knee form. Am J Sports Med. 2001 Sep-Oct;29(5):600-13. doi: 10.1177/03635465010290051301.

  PMID: 11573919 BACKGROUND

• van de Graaf VA, Wolterbeek N, Scholtes VA, Mutsaerts EL, Poolman RW. Reliability and Validity of the IKDC, KOOS, and WOMAC for Patients With Meniscal Injuries. Am J Sports Med. 2014 Jun;42(6):1408-16. doi: 10.1177/0363546514524698. Epub 2014 Mar 11.

  PMID: 24618098 BACKGROUND

• Cooper DE, Fouts B. Single-portal arthroscopy: report of a new technique. Arthrosc Tech. 2013 Jul 19;2(3):e265-9. doi: 10.1016/j.eats.2013.02.017. eCollection 2013.

  PMID: 24265996 BACKGROUND

• Crawford K, Briggs KK, Rodkey WG, Steadman JR. Reliability, validity, and responsiveness of the IKDC score for meniscus injuries of the knee. Arthroscopy. 2007 Aug;23(8):839-44. doi: 10.1016/j.arthro.2007.02.005.

  PMID: 17681205 BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Dr. John Hubbard
• Organization: Wake Forest University

jhubbard@wakehealth.edu

336-998-1297

Study Officials

• Beth P. Smith, PhD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

• John Hubbard

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: December 30, 2020
• Results First Posted: December 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)