NCT01527201

Brief Summary

The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

4.5 years

First QC Date

January 19, 2012

Last Update Submit

April 12, 2021

Conditions

Meniscal TearChondromalacia

Keywords

ArthroscopyDebridement

Outcome Measures

Primary Outcomes (1)

  • Self-reported knee pain

    1-year after surgery

Secondary Outcomes (2)

  • Intra-operative costs associated with debridement (i.e., time and instruments needed to debride)

    Measured during surgery

  • Subjective measures and knee measurements

    1-year after surgery

Study Arms (2)

Treatment Group

EXPERIMENTAL

Worn out cartilage will be surgically treated.

Procedure: Arthroscopic debridement

Control Group

NO INTERVENTION

Worn out cartilage will be observed, but will not be treated surgically.

Interventions

Arthroscopic debridementPROCEDURE

Surgeon will debride, or remove, worn out cartilage.

Also known as: Chondroplasty
Treatment Group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo a meniscectomy
  • Patients with chondral lesions found during meniscectomy
  • Patients without chondral lesions are not eligible for randomization to one of the study arms, but will still be included in the study and observed after surgery

You may not qualify if:

  • Osteochondritis dissecans
  • Large chondral flaps judged to be impending loose bodies
  • Joint space loss of affected compartment greater than 50% compared to opposite side
  • Visible osteophytes of the medial or lateral compartment
  • Previous knee surgery on the affected side
  • Previous major knee trauma
  • History of inflammatory joint disease, gout, or chondrocalcinosis
  • Presence of worker's compensation claim
  • Patients undergoing meniscal repair
  • Patients undergoing microfracture for contained grade IV chondral lesions
  • Presence of significant ligamentous instability in the operative knee (i.e., complete acruciate ligament (ACL) or posterior cruciate ligament (PCL) tear, grade III medial or lateral side instability)
  • Major neurologic deficit
  • Serious medical illness with limited life expectancy or that poses high intraoperative risk
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UB Orthopaedics and Sports Medicine

Buffalo, New York, 14214, United States

Location

Related Publications (2)

  • Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.

    PMID: 18784099BACKGROUND

  • Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.

    PMID: 12110735BACKGROUND

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Leslie Bisson, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 19, 2012

First Posted

February 6, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

US(1)