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A prospective multi-center clinical cohort study of bone removal combined with locking plate internal fixation (BTLP) and traditional bone removal (BT) for the treatment of infectious bone defects

A prospective multi-center clinical cohort study of bone removal combined with locking plate internal fixation (BTLP) and traditional bone removal (BT) for the treatment of infectious bone defects

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117931
Enrollment
Unknown
Registered
2026-01-30
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Osteomyelitis

Interventions

BTLP Technique Treatment Group (Study Group):None.
BT Technique Treatment Group (Control Group):None.

Sponsors

The First Hospital Affiliated to Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years, regardless of gender. 2.Confirmed diagnosis of femoral or tibial bone infection. 3.Willing to undergo a two-stage treatment protocol (Stage I: debridement and bone cement spacer implantation; Stage II: bone defect reconstruction), with effective infection control confirmed after Stage I debridement. 4.Patients selecting the bone transport technique for bone defect reconstruction in Stage II.

Exclusion criteria

Exclusion criteria: 1.Presence of skin and soft tissue defects following Stage I debridement. 2.Bone defect length 2 weeks). 8.Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Bone healing rate at 1 year postoperatively;

Secondary

MeasureTime frame
Infection recurrence rate;External Fixation Index (EFI);Bone Healing Index (BHI);Paley Bone Healing Results;Paley Lower Extremity Functional Results;the MOS item short fromhealth survey, SF-36;Incidence of complications;Pain score (assessed by Visual Analogue Scale);Self-Rating Anxiety Scale;

Countries

China

Contacts

Public ContactFei Luo

The First Hospital Affiliated of Army Medical University

13883846917@163.com+86 138 8384 6917

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026