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Comparison of one-stage calcaneal preserving revision with antibiotic-loaded cement spacer and two-stage calcaneal preserving revision in the treatment of chronic complicated Calcaneal Osteomyelitis – A prospective multi-centric randomized controlled clinical trial

Comparison of one-stage calcaneal preserving revision with antibiotic-loaded cement spacer and two-stage calcaneal preserving revision in the treatment of chronic complicated Calcaneal Osteomyelitis – A prospective multi-centric randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068397
Enrollment
Unknown
Registered
2023-02-17
Start date
2023-02-17
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

chronic complicated Calcaneal Osteomyelitis

Interventions

experimental group :one-stage calcaneal preserving revision with antibiotic-loaded cement spacer
control group:two-stage calcaneal preserving revision

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) over 18 years of age; (2) Recurrence of calcaneal osteomyelitis, or one period beyond 2 months; (3) Soft tissue defects complicated with infection or that cannot be sutured directly; (4) agree to and be able to cooperate with the treatment plan; (5) The patient has been aware of the study and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who do not accept or cannot cooperate with treatment; (2) Patients who have undergone calcaneectomy or large bone and soft tissue defects in the heel area; (3) Congenital or acquired muscle, joint or nervous system diseases affecting lower limb function; (4) There are any other medical conditions or contraindications that preclude participation in the study; (5) Patients with severe allergic history of vancomycin, gentamicin and other antibiotics; (6) Pregnancy or lactation; (7) Inability to understand written/spoken Chinese; (8) any history of mental and psychological illness; (9) Patients with severe liver and kidney insufficiency, poor basic condition or organ deterioration that cannot tolerate surgery; (10) Severe cardiac insufficiency or circulatory system disease affecting daily life and exercise; (11) Patients unable to sign informed consent for personal or other reasons.

Design outcomes

Primary

MeasureTime frame
AOFAS score;infection recurrent rate;

Secondary

MeasureTime frame
Brief Pain Inventory (BPI);short form 36 questionnaire;Amputation rate;Refracture rate of calcaneus;

Countries

PR China

Contacts

Public ContactCheng Pengfei

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

chengpf@alumni.sjtu.edu.cn18930173104

Outcome results

None listed

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