A study to compare results of two different surgeries for treating loss of blood supply of the femoral head in children.

Comparison of radiological and functional outcome of paediatric non traumatic femoral head osteonecrosis managed by core decompression alone versus core decompression and bone marrow concentrate aspirate- a prospective pseudo-randomized study. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082864

Enrollment

Registered

2025-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M873- Other secondary osteonecrosis Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Femoral Head- Core decompression and Bone marrow aspirate concentrate (CD-BMAC) application: CD- BMAC is an routinely performed surgical intervention for avascular necrosis of femoral h

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of Nontraumatic Femoral head osteonecrosis (FHO) by history, clinical examination, and MRI Stage I to stage III osteonecrosis according to Steinberg classification Willingness to participate and provide informed consent.

Exclusion criteria

Exclusion criteria: FHO secondary to trauma, Perthes disease, Developmental Dysplasia of Hip Previous surgery or conservative treatment for FHO Contraindications to Core Decompression (CD) or Bone Marrow Aspirate Concentrate (BMAC), such as infection, malignancy, or allergy

Design outcomes

Primary

Measure	Time frame
Paediatric Outcomes Data Collection Instrument (PODCI).Timepoint: at pre-operative, postoperative six months, one year and two years.	—

Secondary

Measure	Time frame
1. To evaluate the radiographic parameters, such as femoral head sphericity, caput index, joint space width, and osteonecrosis Steinberg stage. 2. Complications, such as infection, fracture, and avascular necrosis progression. 3. Improvement in outcome, using the modified Harris Hip Score (mHHS). 4. To evaluate correlation between functional and radiological outcome in each group, viz Core decompression alone and core decompression followed by bone marrow concentrate application. 5. To quantify the osteoprogenitor cells in the bone marrow aspirate and concentrate and to correlate the functional and radiological score to quality of bone marrow aspirate concentrate. Timepoint: at pre-operative, postoperative six months, one year and two years.	—

Measure

Time frame

1. To evaluate the radiographic parameters, such as femoral head sphericity, caput index, joint space width, and osteonecrosis Steinberg stage. 2. Complications, such as infection, fracture, and avascular necrosis progression. 3. Improvement in outcome, using the modified Harris Hip Score (mHHS). 4. To evaluate correlation between functional and radiological outcome in each group, viz Core decompression alone and core decompression followed by bone marrow concentrate application. 5. To quantify the osteoprogenitor cells in the bone marrow aspirate and concentrate and to correlate the functional and radiological score to quality of bone marrow aspirate concentrate. Timepoint: at pre-operative, postoperative six months, one year and two years.

—

Countries

India

Contacts

Public ContactThomas Palocaren

Christian Medical College Vellore

thomaspalox@cmcvellore.ac.in914162282172

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026