To conduct a randomised controlled trial to determine differences in the level of blood markers for tissue damage and to visualize tissue trauma by means of MRI following the anterior approach and posterolateral approach for THA.Additionally, a…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The levels of serum creatine kinase (CK), creatine phosphokinase (CPK), and
C-reactive protein (CRP) will be assessed.
For the pilot study the reliability of macrophage and monocyte measurements
will be assessed.
Secondary outcome
Tissue damage will additionally be assessed via the enumeration of the tissue
macrophages in blood (over time), preferably also using specific antibodies
against fragments of tissue-specific proteins, such as soft tissue and skeletal
muscle. Multiparameter (* 8 colors) flow cytometry can accurately detect and
identify the circulating tissue macrophages with a first set of antibodies
against membrane markers. A second set of antibodies will be used to detect the
intracellular tissue-specific protein fragments. In case of THA, such
tissue-specific protein fragments have to be determined, e.g. derived from soft
tissues and/or from skeletal muscle. The absolute and relative numbers of the
blood tissue macrophages during and after the THA procedure should be able to
give insight into the extent of tissue damage in individual patients.
Besides a relative and quantitative assessment, another secondary study
parameter will be the presence of bone- and muscle- specific protein fragments
in the circulating macrophages. The presence of these fragments, might be
related to the extent of bone and muscle damage, potentially allowing a more
accurate assessment of damage caused by the different THA approaches. Damage to
tendons and musculature will be visualized by means of MRI. The amount of fatty
atrophy of the muscles and (partial) tendon tears or detachments will be used
to measure the actual damage following THA,
Additionally, surgical time and length of hospital stay will be recorded as
secondary clinical outcome measures.
Background summary
Total hip arthroplasty (THA) is considered to be one of the most successful
orthopaedic interventions of the past 40 years, with 10-year survival rates
exceeding 90%. The number of THAs has increased rapidly during the last decade,
because of ageing of Western societies and an increase of the incidence of
obesity. Driven by this growing demand for THA, together with a greater
emphasis on cost-effectiveness in health care and patients* higher expectations
of shorter hospital stays and faster recovery, alternative surgical procedures
have been developed to improve the success of THA. The anterior approach for
THA is one of these developments. Compared to conventional approaches for THA,
such as the posterolateral approach, the anterior approach for THA is
considered to result in less damage to soft tissues, such as muscles and
tendons. Tissue damage can be assessed by means of biochemical blood markers
such as serum creatine kinase (CK), creatine phosphokinase (CPK), and
C-reactive protein (CRP). It is also known that macrophages are key regulators
of tissue repair and regeneration. Macrophage activity can therefore be another
useful blood marker for the amount of tissue damage. Additionally, changes in
muscle cross-sectional area and fatty atrophy of the muscles that can be
visualised by means of MRI reflect the muscle damage and correlate with muscle
function.
Study objective
To conduct a randomised controlled trial to determine differences in the level
of blood markers for tissue damage and to visualize tissue trauma by means of
MRI following the anterior approach and posterolateral approach for THA.
Additionally, a pilot study will be performed to assess the reliability the
measurements of macrophage and monocyte kinetic activity.
Study design
A randomised controlled trial will be executed. Patients will be randomly
allocated to undergo THA by means of the anterior approach or the
posterolateral approach. The trial will be conducted at the department of
Orthopaedics of the Martini Hospital Groningen.
Prior to the start of the RCT a pilot study will be performed to assess the
reliability the measurements of macrophage and monocyte kinetic activity.
Intervention
Patients in the study group will undergo THA using the minimally invasive
single-incision anterior approach. This approach will be compared to the
conventional posterolateral approach for THA.
Study burden and risks
Since both the anterior and posterolateral approach for THA are standard
approaches for THA, no additional risks are associated with participation of
the study. During hospital stay because of the THA, several blood samples are
taken as part of the standard treatment of patients following THA. Because of
the study, some extra blood samples are taken during hospital stay and during
follow-up. No additional risks are involved with taking these extra blood
samples. No additional risks are involved with MRI.
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
- Age between 18 * 90 years;
- Indication for THA is primary or secondary symptomatic osteoarthritis of the hip joint
Exclusion criteria
- A history of previous surgery on the ipsilateral hip;
- peripheral neuropathy;
- (active) arthritis (e.g. rheumatic disease);
- a history of CVA;
- a contraindication for MRI;
- cognitive impairments.
Design
Recruitment
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 | NL44369.099.13 |