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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Knee Creations, LLC.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014