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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621893
First Posted: June 18, 2012
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  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
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 Zimmer Biomet:

Primary Outcome Measures:
  • Knee Injury Osteoarthritis Outcomes Score (KOOS) Pain Subscore [ Time Frame: One Year ]
    20 point improvement in KOOS Pain Sub-score


Secondary Outcome Measures:
  • Maintenance or improvement in range of motion [ Time Frame: one year ]
  • Maintenance or reduction in use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs), narcotics, anti-inflammatory medications [ Time Frame: one year ]
  • Complications or secondary procedures at index site of knee [ Time Frame: 2 to 5 years ]

Enrollment: 70
Actual Study Start Date: March 26, 2012
Estimated Study Completion Date: April 30, 2022
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BML of the Knee
Subject has single bone marrow lesion of tibia, single BML of femur, or adjoining BML's of tibia & femur on which a Subchondroplasty procedure is performed
Procedure: Subchondroplasty
Other Name: Calcium Phosphate Bone substitute filling of micro fractures

Detailed Description:
This study is designed as a prospective, consecutive series outcomes study. Patients presenting with knee pain associated with bone marrow lesions that meet the inclusion criteria will be eligible to undergo Subchondroplasty procedure. The subjects will be followed for twenty-four (24) months after surgery via office visits and will be contacted once per year for up to 5 years post-operatively and asked questions regarding their pain and functioning to further understand long-term outcomes.. Seventy (70), a ( minimum of sixty-two (62)) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Up to 5 sites will participate in this study. The study is intended to provide an estimate of one-year and two-year clinical success with minimum bias and with sufficient statistical precision to permit meaningful comparison to commonly accepted two-year clinical success rates for currently available treatment alternatives. An improvement of 10 points on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscore on the KOOS Scoring System from baseline to 1-year post-operative is considered minimal perceptible clinical improvement and will be used to define the primary clinical success criterion for this study.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with single bone marrow edema of the tibia, single bone marrow lesion of the femur or adjoining bone marrow lesions of the tibia and femur (kissing lesions).
Criteria

Inclusion Criteria:

  • Subject is 40-70 of age and skeletally mature
  • Subject BMI is < 40
  • Subject has experienced pain in knee for at least 3 months
  • BML is confirmed on T2 weighted MR Imaging by presence of white signal
  • Subject has single BML of tibia, single BML of femur, or adjoining BML's of tibia & femur
  • Baseline KOOS pain subscore is ≤65
  • Subject's involved knee alignment is defined radiographically as one of the following: Neutral, ≤ to 7 degrees mechanical varus or < 7.5 degrees mechanical valgus
  • Subject's 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
  • Subject is willing and able to sign a written consent form
  • The subject has the mental capacity and the willingness to comply with the specified follow-up evaluations, and can be contacted by telephone by the site personnel.

Exclusion Criteria:

  • 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
  • Subject is not neurologically intact (sensory, motor, and reflex deficit)
  • Subject is insulin dependent
  • Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
  • Subject with primary bone tumor in the knee area
  • Subject anticipates having a lower extremity surgery other than the investigational surgery during the course of the study
  • Subject has a history of substance abuse
  • Subject is currently involved in another study or have received investigational product or treatment within the last 30 days
  • Subject is pregnant or planning on becoming pregnant during the study period
  • Subject is accepting workers' compensation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621893


Locations
United States, California
CORE Orthopaedics
Encinitas, California, United States, 92024
United States, Illinois
Hinsdale Orthopedics
New Lenox, Illinois, United States, 60451
United States, New York
Hospital for Joint Disease
New York, New York, United States, 10003
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Allegheny Orthopaedic Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Steadman Hawkins Foundation
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Steven Cohen, MD Rothman Institute
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01621893     History of Changes
Other Study ID Numbers: KC-SCP-001
First Submitted: June 14, 2012
First Posted: June 18, 2012
Last Update Posted: September 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zimmer Biomet:
bone marrow edema
bone marrow defects