Plain English Summary
Background and study aims
Diaphyseal femoral fractures (breaks in the large leg bone) occur in both the young and the elderly. Current methods include intramedullary nailing (having a metal rod forced into the bone), plate fixation, and external fixation (procedures that fix screws or plates to the bone). However, in patients treated with these methods, 0.9 - 4% of nonunion (when the bone fails to heal) rate is reported. The treatment of nonunions is a challenge to orthopedic surgeons. For patients with atrophic femoral diaphyseal nonunions (wasting away of the bone), autologous cancellous bone (bone grafts) is a fairly common practice, with the most common autologous graft donor site being the iliac crest. The incidence of morbidities (co-occuring diseases) related to bone grafts is as high as 22%. To minimize the drawbacks associated with traditional bone grafting, percutaneous approaches (made through the skin) have been developed for harvesting autologous bone marrow. However, not all patients who undergo this procedure experience satisfactory healing, and the incidence of nonunion after BM injection continues to be high, at 18 - 37%. Prior to this study, we carefully assessed the drawbacks associated with previously reported autologous BM transplantation procedures, and designed a modified surgical method. This study is to examine the outcomes of multidirectional percutaneous drilling combined with autologous concentrated BM transplantation for atrophic femoral diaphyseal nonunions characterized by intact hardware and mechanical stability at the nonunion site.
Who can participate?
Adults aged 18 or over who have an atrophic nonunion of femoral diaphysis.
What does the study involve?
All participants undergo combined multidirectional percutaneous drilling and autologous BM transplantation. Surgery is scheduled after completing the routine examination, which will take approximately two-three days. Around four to five days of observation period is arranged after operation.Following the surgery, participants return every month and the second-stage follow-up are carried out at each visit. Participants are followed up to see how well their bones healed and if there were any complications.
What are the possible benefits and risks of participating?
There are no direct benefits. Bone union is expected. The related technique is already mature. Local complication is rarely reported. Possible complications include mild pain, redness or swelling in the operation area.
Where is the study run from?
Chinese PLA General Hospital (CN)
When is study starting and how long is it expected to run for?
January 2008 to June 2018
Who is funding the study?
Chinese PLA General Hospital (CN)
Who is the main contact?
Professor Peifu Tang
Trial website
Contact information
Type
Scientific
Primary contact
Prof Peifu Tang
ORCID ID
Contact details
Department of Orthopaedics
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Type
Public
Additional contact
Dr Yutong Meng
ORCID ID
Contact details
Department of Orthopaedics
Chinese PLA General Hospital
28 Fuxing Road
Haidian District
Beijing
100853
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Not Applicable
Study information
Scientific title
Clinical outcome of a modified autologous BM transplantation vs. previously reported BM transplantation for the treatment of femoral diaphyseal nonunions
Acronym
Study hypothesis
Combined multidirectional percutaneous drilling and autologous BM transplantation performs better than traditional autologous BM transplantation alone in femoral diaphyseal nonunions.
Ethics approval
Institutional Ethical Review Committee of Chinese PLA General Hospital, 01/12/2008
Study design
A prospective single-center single-group interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Femoral diaphyseal nonunions
Intervention
This study is a prospective single-group interventional study. All the participants in this study are allocated to the treatment group. All participants undergo the surgery of combined multidirectional percutaneous drilling and autologous BM transplantation. Surgery is scheduled after completing the routine examination, which will take approximately two-three days. Around four to five days of observation period is arranged after operation. The first-stage treatment will last for 6-8 days.
Following the surgery, participants return every month and the second-stage follow-up will be carried out at each visit. The follow-up items are listed as follows:
1. Radiographic examinations
2. RUST score based on radiographic evaluation
3. Any postoperative complications
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Healing condition of cortices is measured using the Radiographic Union Scale for Tibial fractures (RUST) every month after operation
2. Bony union time is recorded when radiographic union is achieved, which was diagnosed by a RUST score ≥ 10
Secondary outcome measures
1. Postoperative complications is collected from medical records at discharge from hospital
2. Health Economic assessment is assessed using length of hospital stay and serious adverse events including death within 90 days of surgery
Overall trial start date
01/07/2008
Overall trial end date
30/06/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Presenting with atrophic nonunion of femoral diaphysis
2. Adults aged 18 or over
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Participant with local angular deformity
2. Participant with extremity shortening
3. Participant with internal fixation failure
4. Participant with mental comorbidity
Recruitment start date
01/01/2009
Recruitment end date
30/09/2013
Locations
Countries of recruitment
China
Trial participating centre
Chinese PLA General Hospital
100853
China
Funders
Funder type
Not defined
Funder name
Chinese PLA General Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Analysis of relevant data of this study is being carried out. The main results will be published in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
01/01/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list