To assess the clinical and cost effectiveness of the anterior approach, compared to the conventional posterolateral approach for THA in terms of physical functioning and health-related quality of life
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the Patient Acceptable Symptom State (PASS) which will
be derived from the Hip disabilities and Osteoarthritis Outcome Score (HOOS).
Secondary outcome
Physical functioning and health-related quality of life will be determined
subjectively by means of questionnaires. Additionally, physical functioning
will assessed objectively by means of gait function measurements
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, during surgery in order to enhance postoperative recovery and,
consequently, in an accelerated return to normal daily functioning. It is
expected that elderly patients (aged 70 years and over) may benefit even more
from the anterior approach, because of their decreased regenerative capacity to
recover from tissue damage. However, there is a lack of well-designed studies,
and thus of objective evidence, on the (cost)effectiveness of the anterior
approach, with special attention to its effect on elderly THA patients.
Study objective
To assess the clinical and cost effectiveness of the anterior approach,
compared to the conventional posterolateral approach for THA in terms of
physical functioning and health-related quality of life
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.
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.
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. With gait function, walking pattern of the patients is assessed.
Patients do not have to perform motor tasks which they are not used to perform.
So no risks are involved with the gait function measurements.
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.
Exclusion criteria
- A history of previous surgery on the ipsilateral hip;
- symptomatic osteoarthritis of the contralateral hip;
- a hip prosthesis at the contralateral side <= 2 years before;
- symptomatic osteoarthritis of the knee;
- peripheral neuropathy;
- (active) arthritis (e.g. rheumatic disease);
- a history of CVA;
- COPD GOLD III or IV
- NYHA class III or IV
- cognitive impairments;
- not able to fill in questionnaires in the Dutch language.
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 |
|---|---|
| Other | 21941 |
| CCMO | NL53266.099.15 |