Primary Objective: To compare the function and strength of the hip of patients with a trochanteric fracture with and without a fracture of the lesser trochanter.Secondary Objective(s):The following parameters will be assessed and compared for…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is the function and strength of the hip 12
months after surgery measured with the HHS.
Secondary outcome
* Pain measured with a visual analogue scale on day 2 and at 6 weeks, 3 and 12
months after surgery.
* Migration of the lesser trochanter fragment on X-ray examinations in patients
with trochanteric fractures with lesser trochanter involvement before surgery
and at 6 weeks, 3 and 12 months after surgery.
* Quality of life measured with a quality of life questionnaire (EQ-5D) before
surgery and at 6 weeks, 3 and 12 months after surgery.
* Duration of hospital stay (days).
* Duration of rehabilitation centre stay (days).
* Mental status measured with 6CIT-score before surgery and at 6 weeks and 12
months after surgery.
* Patient reported general mobility measured with the Katz before surgery and
at 6 weeks, 3 and 12 months after surgery.
* The incidence and type of surgical related complications: deep and
superficial wound infection, postoperative bleeding, 60-day and 1-year
re-operation rate, and implant related failures (implant failure, implant
dislocation, periprosthetic fracture).
* The incidence and type of non-surgical related complications: hospital,
60-day and 1-year mortality delirium, pneumonia, cardiac complications, urinary
tract infections, urinary retention, deep venous thrombosis, pulmonary
embolism, pressure sores, and rate of underfeeding on admission (Mini
Nutritional Assessment MNA).
Background summary
The incidence of proximal femoral fractures has steadily increased in the last
few decades in accordance with the rise of the elderly population. Proximal
femoral fractures can be categorized into femoral neck fractures and
trochanteric fractures. The latter are classified as stable or unstable,
depending on the integrity of the medial cortex. Although unstable trochanteric
fractures often have a concomitant fracture of the lesser trochanter, little
has been published about the dynamic and functional consequences of this
specific involvement. The fragmented lesser trochanter, however, could play a
major role in the rehabilitation process not only because the medial buttress
is compromised, but also because it is the insertion point of the main flexor
muscle and stabiliser of the hip: the iliopsoac muscle.
Study objective
Primary Objective:
To compare the function and strength of the hip of patients with a trochanteric
fracture with and without a fracture of the lesser trochanter.
Secondary Objective(s):
The following parameters will be assessed and compared for patients with a
trochanteric fracture with and without a fracture of the lesser trochanter:
* Patient reported pain in the hip region.
* Incidence and type of surgical complications.
* Incidence and type of non-surgical complications.
* Rehabilitation centre stay.
* Patient reported general mobility.
* Patient reported quality of life.
And:
* Migration of the lesser trochanter in patients with a trochanteric fracture
with a fracture of the lesser trochanter on X-ray examinations.
Study design
Single centre prospective observational patient-cohort study.
Study burden and risks
Participation in the study will not pose any additional risks for the patient.
Patients will receive standard care and routine follow-up during a period of 12
months postoperatively, participants will be asked to come to the hospital for
2 additional visits. All measurements will be performed during these visits.
The burden for the patients will include filling out a limited number of
questionnaires and a few non-invasive measurements.
bronovolaan 5
Den Haag 2597 AX
NL
bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
- Unilateral trochanteric fracture AO type 31 A1, A2 of A3.
- Age * 70 years.
- Fracture suitable for fixation with PFNa.
Exclusion criteria
- Other fractures restricting rehabilitation.
- High energy fracture of the hip.
- Malignant fractures.
- Previous fractures of the ipsi- or contralateral hip or femur.
- Non operative treated hip fractures.
- Injury Severity Score > 15.
- Patients incapable of physical therapy for rehabilitation by dementia
- Patients incapable of physical therapy for rehabilitation by physical restrictions.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54746.098.16 |