NCT05314608

Knee Related Subchondral Bone Lesions Treated With IOBP

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Arthrex, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subchondral Cyst

Interventions

Type	Name	Description
COMBINATION_PRODUCT	IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee	Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

Timeline

• Start date: 2021-11-17
• Primary completion: 2027-05-17
• Completion: 2027-05-17
• First posted: 2022-04-06
• Last updated: 2022-12-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study