Non traumatic osteonecrosis of the femoral head, ARCO stages II-III, hip pain and functional limitations
Conditions
Interventions
Single arm treatment group:3D printing absorbable artificial bone combined with intraoperative autologous bone marrow cell enrichment for hip preservation treatment
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 60 years old, male or female not limited; 2.Confirmed by clinical and imaging examinations as non traumatic osteonecrosis of the femoral head, ARCO stage II-III, planned to undergo hip preservation treatment; 3.The etiology can be classified as steroid, alcohol, or idiopathic osteonecrosis of the femoral head; 4.There are clinical symptoms such as hip pain and limited mobility, and there is a need for hip protection treatment; 5.Voluntarily participate in this study, understand the research purpose, process, potential benefits and risks, and sign a written informed consent form; 6.Willing to accept 3D printed absorbable artificial bone combined with intraoperative autologous bone marrow cell enrichment for hip preservation treatment, and cooperate with follow-up and related sample collection;
Exclusion criteria
Exclusion criteria: 1.Femoral head necrosis caused by traumatic femoral neck fracture or other clearly defined traumatic factors; 2.Patients with severe collapse of the femoral head, ARCO IV stage, or severe degeneration of the hip joint are not suitable for hip preservation treatment; 3.Individuals with concurrent active infections, severe heart, lung, liver, and kidney dysfunction, coagulation dysfunction, or other serious systemic diseases; 4.Individuals known to be allergic to absorbable artificial bone materials such as ß - TCP, PCL, or perioperative medications; 5.Pregnant or lactating women, or those with recent pregnancy plans; 6.Participants in other interventional clinical studies within the past 3 months; 7.Other situations that the researcher deems unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month postoperative survival rate of femoral head imaging;Harris hip joint function score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hip preservation failure and switch to total hip arthroplasty rate;Visual Analog Score for Hip Pain;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactYuanqing Mao
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Outcome results
None listed