Currently submitted to: JMIR Research Protocols
Date Submitted: Aug 20, 2026
Open Peer Review Period: Aug 20, 2026 - Oct 15, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Intra-Articular Medical Oxygen-Ozone Injections Versus Multiple-Drilling Core Decompression for Early-Stage Osteonecrosis of the Femoral Head: Protocol for a Prospective Nonrandomized Comparative Clinical Study
ABSTRACT
Background:
Osteonecrosis of the femoral head (ONFH) commonly affects working-age adults and may progress to subchondral collapse and total hip arthroplasty. Core decompression is an established joint-preserving option for selected early-stage disease, whereas intra-articular medical oxygen-ozone injection is less invasive but supported by limited ONFH-specific comparative evidence.
Objective:
This study aims to compare 6-month clinical, functional, radiological, and safety outcomes of intra-articular medical oxygen-ozone injections with multiple-drilling core decompression in adults with early-stage ONFH.
Methods:
This prospective, single-center, nonrandomized comparative clinical study will enroll 50 adults aged 18-60 years with symptomatic ARCO stage I, II, or IIIA ONFH. Twenty-five participants will be assigned to each group according to documented clinical suitability and participant preference. The ozone group will receive five weekly ultrasound-guided intra-articular injections of 15 mL medical oxygen-ozone mixture at concentrations of 15, 20, 25, 25, and 25 micrograms/mL. The decompression group will undergo fluoroscopy-guided multiple small-diameter drilling without bone graft or biological adjunct. Both groups will receive standardized analgesia and rehabilitation. The primary outcome is change in Harris Hip Score from baseline to 6 months. Secondary outcomes include pain, range of motion, satisfaction, radiological progression, rescue surgery, and adverse events. Analysis of covariance will compare 6-month Harris Hip Score between groups, adjusting for baseline score and ARCO stage.
Results:
Ethics approval was obtained (DMIHER(DU)/IEC/2025/100), and the study is registered with CTRI (CTRI/2026/04/108039). As of August 6, 2026, recruitment had not begun.
Conclusions:
This study will provide preliminary comparative evidence regarding ozone therapy and core decompression for early-stage ONFH. Clinical Trial: Clinical Trials Registry - India CTRI/2026/04/108039.
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