Knee Related Subchondral Bone Lesions Treated With IOBP (IOBP)

Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).

Study Overview

• Status: Recruiting
• Conditions: Subchondral Cyst
• Intervention / Treatment: Combination product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee

Detailed Description

The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution.

The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Justin W Moss, DHSc; Phone Number: 770 584 4972; Email: justin.moss@arthrex.com
• Study Contact Backup: Name: Alicia Ruiz, MS; Phone Number: 71970 1 (800) 933-7001

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80222
      • Recruiting
      • University of Colorado Sports Medicine
      • Contact: Rachel Frank
      • Principal Investigator: Rachel Frank
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Recruiting
      • Andrews Research and Education Foundation
      • Contact: Adam Anz; Phone Number: 850-916-8575
      • Principal Investigator: Adam Anz
  • Maryland
    • Salisbury, Maryland, United States, 21801
      • Recruiting
      • TidalHealth Peninsula Regional, Inc.
      • Contact: Jason Scopp
      • Principal Investigator: Jason Scopp
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University
      • Contact: David Flanigan
      • Principal Investigator: David Flanigan
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny-Singer Research Institute
      • Contact: Brian Mosier
      • Principal Investigator: Brian Mosier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management.

Description

Inclusion Criteria:

1. Able to read, understand, sign and complete informed consent
2. Male or female subject between the ages of 18-60 years
3. Subject has had pain for greater than three months
4. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure
5. Subject has stable ligaments
6. Subject has neutral alignment (max 5° varus or valgus)
7. Subject has a VAS score greater than or equal to five
8. Subject is scheduled to undergo surgical intervention using IOBP®

Exclusion Criteria:

1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
2. Subject has had lower extremity surgery within six months
3. Subject has had more than two prior surgical procedures in the operative leg
4. Subject has a neuromuscular condition
5. Subject has a current infection
6. Subject has a BMI >35
7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
8. Subject has joint surface collapse in late stage avascular necrosis
9. Subject has majority of pain associated with alternate conditions
10. Subject has had subchondral bone pathology caused by acute trauma
11. Subject is not neurologically intact.
12. Subject has history of invasive malignancy (except non-melanoma skin cancer)
13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
14. Subject has an active substance abuse problem
15. Subject is currently taking narcotic pain medication
16. Subject is pregnant or planning to become pregnant
17. Subject is on worker's compensation
18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
19. Inability to complete study requirements and follow-up visits
20. Subject that has a bone marrow aspiration that does not meet 60cc

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with subchondral bone pathology	Combination product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee; Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of additional surgery into the target knee	To evaluate if IOBP® procedure will prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale (VAS)	Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0	Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op.
International Knee Documentation Committee Subjective Knee Evaluation Form	A patient-oriented questionnaire that assesses symptoms and function in daily living activities. The purpose of this study was to validate the IKDC Subjective Knee Form in a large patient population with various knee disorders.	knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury.	Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op
X-rays of the knee	Images include weight-bearing AP, 45 degree weight bearing PA, lateral and merchant views. Images taken to determine location and status of subchondral bone lesion.	6 months and 1 year
MRI of the knee	Minimum 1.5 Tesla MRI (including coronal, axial, sagittal, lateral femur, and lateral tibial views). Image taken to determine location and status of subchondral bone lesion.	6 months and 1 year

Collaborators and Investigators

• Sponsor: Arthrex, Inc.
• Investigators: Principal Investigator: Adam Anz, Andrews Research and Education Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Anticipated): May 17, 2027
• Study Completion (Anticipated): May 17, 2027

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Musculoskeletal Diseases; Bone Diseases; Bone Cysts
• Other Study ID Numbers: 20085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No