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NCT Number: NCT05314608

Knee Related Subchondral Bone Lesions Treated With IOBP

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).

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Key information

Conditions

Subchondral Cyst Bone Cysts Bone Diseases Cysts Musculoskeletal Diseases Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Sports Medicine, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to read, understand, sign and complete informed consent
  • Male or female subject between the ages of 18-60 years
  • Subject has had pain for greater than three months
  • 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
  • Subject has stable ligaments
  • Subject has neutral alignment (max 5° varus or valgus)
  • Subject has a VAS score greater than or equal to five
  • Subject is scheduled to undergo surgical intervention using IOBP®

Exclusion criteria

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

Treatment and study plan

IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee

Combination Product

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

Primary outcomes

  1. Prevention of additional surgery into the target knee

    Time frame: 5 years

    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.

Secondary outcomes

  1. 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.

    Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0

  2. 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.

    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.

  3. 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

    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.

  4. X-rays of the knee

    Time frame: 6 months and 1 year

    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.

  5. MRI of the knee

    Time frame: 6 months and 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Ruiz, MS

CONTACT

1 (800) 933-7001 ext. 71970

Justin W Moss, DHSc

CONTACT

[email protected]

770 584 4972

Sponsors and collaborators

Lead sponsor

Arthrex, Inc.

Industry

Registry information

Official study title

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

Acronym: IOBP

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2022
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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