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Efficacy of Synovectomy in the Treatment of Femoral Head Osteonecrosis with Vascularized Fibular Grafting: a Single-Center Randomized Clinical Trial (SYNERGY-VGF Trial)

Efficacy of Synovectomy in the Treatment of Femoral Head Osteonecrosis with Vascularized Fibular Grafting: a Single-Center, Two-Arm, Double-Blind, Randomized, Superiority Clinical Trial - SYNERGY-VGF Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073385
Enrollment
Unknown
Registered
2023-07-10
Start date
2023-07-10
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Femoral Head Osteonecrosis

Interventions

Experimental Group:hip joint synovectomy during the vascularized free fibular grafting procedure for the treatment of femoral head necrosis
Control Group:Not performing hip joint synovectomy during the vascularized free fibular grafting procedure for the treatment of femoral head necrosis

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-50 years; 2. Necrosis of the femoral head of the affected hip joint meeting the 2019 ARCO staging of stage I, II, and IIIA; 3. Synovitis of the affected hip joint; 4. Hip joint symptoms persisting for 6 months; 5. Moderate to severe hip pain (NRS >= 3, on a scale of 0-10, 0 = no pain).

Exclusion criteria

Exclusion criteria: 1. History of surgery on the affected hip joint; 2. Current or past history of infection in the affected hip joint; 3. History of inflammatory arthritis, osteonecrosis, or Paget's disease in the affected hip joint; 4. Planned total hip replacement surgery on the affected hip joint within the next 6 months; 5. Pregnant or breastfeeding women; 6. Individuals with a bleeding disorder or currently receiving anticoagulant therapy; 7. Individuals who have or had cancer or a tumor; 8. Unable to understand written/spoken Chinese; 9. Individuals with any history of mental or psychological disorders.

Design outcomes

Primary

MeasureTime frame
Harris score (0-100) change;

Secondary

MeasureTime frame
hip pain numerical rating scale (NRS) score;Depression Anxiety and Stress Scale, DASS-21;EuroQol five-dimension questionnaire (EQ-5D);

Countries

China

Contacts

Public ContactYoushui Gao

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

gaoyoushui@sjtu.edu.cn+86 189 3017 3109

Outcome results

None listed

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