shaped corticotomy with bone flap sliding in the management of chronic tibial osteomyelitis: Surgical Technique and Clinical Results
Not Applicable
Completed
- Conditions
- Chronic tibial osteomyelitisMusculoskeletal Diseases
- Registration Number
- ISRCTN11137938
- Lead Sponsor
- Orthopaedic Department, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Brief Summary
2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30755228/ (added 06/12/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
1. Aged 18 years or older
2. Patients with chronic osteomyelitis only involving the anterior tibial cortex
Exclusion Criteria
1. Diffuse osteomyelitis affecting both anterior and posterior cortices of the tibia
2. Severe neuro-vascular damage or mental disease or any other conditions which might lead to lack of cooperation
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. The external fixation time (EFT) represented the total number of days the external fixator was attached to the bone, calculated at the last follow-up<br> 2. The external fixation index (EFI), defined as the duration of external fixation in days divided by the total amount of lengthening in cm, calculated at the last follow-up<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Pin tract inflammation was made according to Dahl’s grading every month after surgery<br> 2.. Bone healing criteria according to the criteria of Paley at the last follow-up<br> 3.. Bone functional results according to the criteria of Paley at the last follow-up<br> 4. Rate of bridging of at least three out of four cortices assessed by X-ray prior to the segmental excision and then at 2-weekly intervals.<br> 5. Impact of the musculoskeletal condition assessed using Short-form Musculoskeletal Function Assessment (SMFA) questionnaire at 2, 12 and 25 weeks<br> 6. Quality of life assessed using the 36-item Short Form Health Survey (SF36) at 2, 12 and 25 weeks<br> 7. Pain assessed using a visual analogue scale (VAS) with results taken in line with standard care<br>