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Recruiting NCT05314608

Knee Related Subchondral Bone Lesions Treated With IOBP

— Observational Subchondral Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee.
Who it may be relevant to
Registry conditions: Subchondral Cyst. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Combination product IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
    Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

Primary outcome measures

  • Prevention of additional surgery into the target knee [Time frame: 5 years]
Secondary outcome measures (5)
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 5 centers
  • University of Colorado Sports Medicine — Denver
  • Andrews Research and Education Foundation — Gulf Breeze
  • TidalHealth Peninsula Regional, Inc. — Salisbury
  • The Ohio State University — Columbus
  • Allegheny-Singer Research Institute — Pittsburgh

Identifiers

NCT: NCT05314608 · 20085

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗