Extracorporeal shockwave therapy combined with multiple drilling and intramedullary drug injection for treating early-stage Femur Head Necrosis: protocol for a randomized controlled trial

To evaluate the efficacy and safety of extracorporeal shock wave therapy combined with multiple drilling and intramedullary drug injection in the treatment of early-stage Avascular Necrosis of Femur Head, A single-center, prospective, randomized controlled clinical Trial.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900020888

Enrollment

Unknown

Registered

2019-01-21

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

Avascular Necrosis of Femur Head

Interventions

Group EMI:ESWT + Multiple drilling + intramedullary drug injection

Group E:Extracorporeal shock wave therapy

Group MI:Multiple drilling + intramedullary drug injection

Group M:Multiple drilling

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Patients between the ages of 20 and 60 years; (2) Patients with a clinical diagnosis of ONFH, staged as ARCO I-II; (3) Patients who would voluntarily participate in the trial and agree to sign the relevant written consent.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of hip fracture or surgery; (2) Patients who consumed hormones or alcohol within the last 1 month; (3) Patients undergoing any other treatment; (4) Patients who were pregnant or lactating; (5) Patients who were allergic to relevant drugs used in this study; (6) Patients with other hip diseases or serious medical diseases.

Design outcomes

Primary

Measure	Time frame
Subchondral collapse rate of the femoral head;Lesion size;Grade of Bone Marrow Edema;Effective rate;	—

Secondary

Measure	Time frame
Visual analog scale;Harris hip score;	—

Countries

China

Contacts

Public ContactFan Xiaohong

Hospital of Chendu University of Traditional Chinese Medicine

44303427@qq.com+86 18981883960

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026