Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/09/2017
Date assigned
21/09/2017
Last edited
21/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Intertrochanteric fractures (fractures that occur in the upper part of the thigh bone) are the most common fractures especially among elderly patients, accounting for 40 - 50% of all hip fractures. Early surgical intervention is usually the best strategy to fix this. The use of intramedullary fixation (the use of a locking rod) has increased in recent years due to its theoretic advantages and biomechanical superiority over extramedullary fixation (where the hip is stabilized on the outside of the thigh by puns or screws driven into the bone), especially in the unstable fracture patterns. However, complication rates of up to 20.5% have been reported using the intramedullary nail technique, and the two most common complications are excessive sliding of the cephalic nail and cut-out. The aim of this study is to examine medical reviews of patients to see if patietns with good reduction quality of the medial and anteromedial sustainable cortices had better clinical outcomes and lower complication rates.

Who can participate?
Adults aged 60 years and older who have fallen indoors or outdoors and suffered from the intertrochanteric fractures.

What does the study involve?
This is a chart review study. Participants who underwent internal fixation using a intramedullary nail are reviewed. They are are classified based on scans taken after the surgery. Their post-surgery scans and their three month follow up data are used to calculate their mobility and complications.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
Chinese PLA General Hospital (China)

When is the study starting and how long is it expected to run for?
January 2010 to December 2017

Who is funding the study?
Shoufazhuanxiang (China)

Who is the main contact?
Dr Jiantao Li
lijiantao618@163.com
Professor Peifu Tang
pftang301@163.com

Trial website

Contact information

Type

Public

Primary contact

Dr Jiantao Li

ORCID ID

Contact details

No. 28 Fuxing Road
Beijing
100853
China
+86 10 68212342
lijiantao618@163.com

Type

Scientific

Additional contact

Prof Peifu Tang

ORCID ID

http://orcid.org/0000-0003-4279-1704

Contact details

No. 28 Fuxing Road
Beijing
100853
China
+86 10 68212342
pftang301@163.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Reduction quality of medial and anteromedial sustainable cortices influences the postoperative outcome following intramedullary fixation of 31-A2 intertrochanteric fractures: A retrospective study based on CT findings

Acronym

Study hypothesis

Patients with good reduction quality of the medial and anteromedial sustainable cortices had better clinical outcomes and lower complication rates.

Ethics approval

Ethics Committee of the Chinese PLA General Hospital, 10/05/2009

Study design

Retrospective chart review

Primary study design

Observational

Secondary study design

Case series

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

31-A2 intertrochanteric fractures: fracture extends over two or more levels of medial cortex

Intervention

This is a retrospective study. All patients underwent closed reduction and internal fixation (CRIF) with the intramedullary nail. The CT data of 43 patients with 31-A2 intertrochanteric fractures who underwent closed reduction and intramedullary internal fixation (CRIF) in the institution between January 2010 and December 2013 are retrospective analysed. All patients were classified to one of two groups based on the postoperative CT scans taken from the sagittal and coronal planes, respectively. The radiographic parameters of femoral neck-shaft angle (FNSA), sliding distance of the cephalic nail, femoral head height (FHH) and tip-cortex distance (TCD) on the newly resliced coronal plane are measured. The immediate postoperative CT findings and the three-month follow-up data are both used for measuring the parameters and the changes are calculated. Clinical parameters like Harris hip score, timed “up & go” test and Parker-Palmer mobility score to evaluate the postoperative functional states and mobilisation levels at the final follow-up are measured. In addition to this, postoperative complications are also recorded. All the parameters between different groups are compared. The total duration of follow-up was six to 24 months.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Radiographic parameters including Mean loss of the femoral neck-shaft angle (FNSA), sliding distance of cephal nail, change of Tip-cortex distance (TCD), change of Femoral head height (FHH) are measured using the Mimics software (Materialise, Leuven, Belgium) at three month follow up.

Secondary outcome measures

1. Hip function of patient was measured using Harris hip score (HHS) at the final follow-up
2. Time taken to rise from a sitting position and walk for 20 m is measured using timed “Up & Go” (TUG) test at the final follow-up
3. Functional level was also measured using the Parker-Palmer mobility score at the final follow-up
4. We defined loss of reduction as the loss of NSA greater than 10°, which is measured using the CT or radiographs
5. Cut-out is measured using the radiographs during the follow-up
6. Excessive sliding was defined as sliding distance ≥ 10 mm, which is measured using the CT or radiographs
7. Implant breakage is measured using the CT or radiographs during the follow-up

Overall trial start date

01/01/2010

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute unilateral closed fractures
2. At least 3 consecutive (preoperative, within one-week postoperative, 3-months follow-up) CT examinations in addition to the X-ray radiographs
3. Patients aged 60 years and older
4. Follow-up periods of more than six months postoperatively
5. Nail shafts with the static distal locking

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

43

Participant exclusion criteria

1. Pathological fractures such as carcinomas, metastases of the bone, primary malignant or benign tumors, and metabolic disorders
2. Mental disorders
3. Walking with assistive devices before the fractures
4. Fractures with associated neurovascular injuries
5. Pre-existing osteoarthritis or previous surgeries to the affected hip joints

Recruitment start date

01/06/2011

Recruitment end date

01/07/2015

Locations

Countries of recruitment

China

Trial participating centre

Chinese PLA General Hospital
No. 28 Fuxing Road
Beijing
100853
China

Sponsor information

Organisation

Chinese PLA General Hospital

Sponsor details

No. 28 Fuxing Road
Beijing
100853
China
+86 10 68212342
lijiantao618@163.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Shoufazhuanxiang

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Li (lijiantao618@163.com).

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes