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RecruitingObservational

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

NCT ID: NCT05314608Sponsor: Arthrex, Inc.Last updated: 2022-12-05

Summary

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).

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.

Arms & interventions

  • Combination ProductIntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee

    Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

Outcome measures

Primary

  • 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.

    Time frame: 5 years

Secondary

  • Visual Analog Pain Scale (VAS)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 6 months and 1 year

  • MRI of the knee

    Time frame: 6 months and 1 year

Eligibility criteria

Sex: AllAge: 18 Years to 60 YearsHealthy volunteers: No
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 locations (5)

University of Colorado Sports Medicine

Denver, Colorado, 80222

Recruiting
Rachel Frank · Contact
Rachel Frank · Principal Investigator

Andrews Research and Education Foundation

Gulf Breeze, Florida, 32561

Recruiting
Adam Anz · Contact
850-916-8575
Adam Anz · Principal Investigator

TidalHealth Peninsula Regional, Inc.

Salisbury, Maryland, 21801

Recruiting
Jason Scopp · Contact
Jason Scopp · Principal Investigator

The Ohio State University

Columbus, Ohio, 43201

Recruiting
David Flanigan · Contact
David Flanigan · Principal Investigator

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, 15212

Recruiting
Brian Mosier · Contact
Brian Mosier · Principal Investigator