Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions (SCP)

This study is currently recruiting participants.
Verified June 2012 by Knee Creations, LLC
Sponsor:
Information provided by (Responsible Party):
Knee Creations, LLC
ClinicalTrials.gov Identifier:
NCT01621893
First received: June 14, 2012
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.


Condition Intervention
Bony Defects Associated With Bone Marrow Edema
Procedure: Subchondroplasty

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Efficacy Evaluation of Subchondroplasty™ for the Treatment of Defects Associated With Tibial Bone Marrow Lesions

Resource links provided by NLM:


Further study details as provided by Knee Creations, LLC:

Primary Outcome Measures:
  • KOOS Pain Subscore [ Time Frame: One Year ] [ Designated as safety issue: No ]
    20 point improvement in KOOS Pain Sub-score


Secondary Outcome Measures:
  • Maintenance or improvement in range of motion [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Maintenance or reduction in use of NSAIDs, narcotics, anti-inflammatory medications [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Complications or secondary procedures at index site of knee [ Time Frame: 2 to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single Tibial BML's
Patients showing bone marrow edema on T2 FS MRI of one compartment of the tibia only
Procedure: Subchondroplasty
the Subchondroplasty procedure for treatment of bony defects associated with bone marrow edema

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with bone marrow edema of the tibia

Criteria

Inclusion Criteria:

  • Age 40-70 of age and skeletally mature
  • BMI is < 40
  • Subject has experienced pain in knee for at least 3 months
  • Kellgren-Lawrence Grade 2-3 osteoarthritis severity as defined by radiographic examination.
  • BML is confirmed on T2 weighted MR Imaging by presence of white signal
  • BML identified in no more than one compartment of the tibia
  • Baseline KOOS pain subscore is ≤65
  • Subject's involved knee alignment is defined radiographically as one of the following: Neutral, ≤ to 7 mechanical varus or < 7.5 mechanical valgus
  • ACL and PCL ligaments are intact
  • Subject has failed no more than one operative treatment on treatment knee, and none within 6 months prior to enrollment

Exclusion Criteria:

  • More than one BML in tibia
  • BML exists in the femur
  • Surgeon deems subject's pain to be primarily related to an alternate condition such as a baker cyst, synovitis, meniscal pathology, or other
  • BML caused by acute trauma
  • Grade 4 OA as determined by radiographic analysis
  • Subject is not neurologically intact (sensory, motor, and reflex deficit)
  • Subject anticipates having another lower extremity surgery
  • Subject is currently involved in another study
  • Subject is pregnant or planning on becoming pregnant during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621893

Contacts
Contact: Meenal Lele 484-887-8897 mlele@kneecreations.com

Locations
United States, Illinois
Hinsdale Orthopedics Recruiting
Hinsdale, Illinois, United States
Contact: Nathan Hawkins       nathan.hawkins@hoasc.com   
Principal Investigator: Robert Daley, MD         
United States, New York
Hospital for Joint Disease Recruiting
New York, New York, United States
Contact: Cara Fontaine       Cara.Fontaine@nyumc.org   
Principal Investigator: Thomas Youm, MD         
Sub-Investigator: Laith Jazrawi, MD         
Hospital for Special Surgery Recruiting
New York, New York, United States
Contact: Trishna Nath       natht@hss.edu   
Principal Investigator: Edwin Su, MD         
Sub-Investigator: Anil Ranawat, MD         
United States, Pennsylvania
Rothman Institute Recruiting
Philadelphia, Pennsylvania, United States
Contact: Jenny Cai       Jenny.Cai@rothmaninstitute.com   
Principal Investigator: Steven Cohen, MD         
Sponsors and Collaborators
Knee Creations, LLC
  More Information

No publications provided

Responsible Party: Knee Creations, LLC
ClinicalTrials.gov Identifier: NCT01621893     History of Changes
Other Study ID Numbers: KC-SCP-001
Study First Received: June 14, 2012
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Knee Creations, LLC:
bone marrow edema

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014