To evaluate the cost-effectiveness of a treatment algorithm for patients with a complete ACL rupture compared to current used treatment strategy, over a follow-up period of 2 years. With the treatment algorithm faster recovery of functional outcome…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Recovery of physical functioning during 2 years assessed by the IKDC
questionnaire. Besides, differences in medical consumption, absence from work
or decreased productivity, and patient costs, will be assessed.
Secondary outcome
- Return to sport activity and level of sport activity: Tegner score.
- Knee pain: number rating scale (NRS)
- Knee specific outcome score (Knee Injury and Osteoarthritis Outcome Score
(KOOS))
- Satisfaction with treatment
- Kinesiophobia: Tampa scale
- General quality of life: EQ-5D-5L
- total costs: intramural and extramural medical costs (iMCQ) and productivity
loss (iPCQ);
- adverse events
- physical examination, stability tests of the knee: Lachman, anterior drawer
and pivot shift tests
Background summary
It is unknown what the most optimal treatment is for the individual patient
with an anterior cruciate ligament (ACL) rupture.
Study objective
To evaluate the cost-effectiveness of a treatment algorithm for patients with a
complete ACL rupture compared to current used treatment strategy, over a
follow-up period of 2 years. With the treatment algorithm faster recovery of
functional outcome will be achieved compared to the current practice
(superiority study). We expect that a faster recovery of functional outcome
will lead to a faster return to work and sports. Hence, we hypothesize that the
treatment algorithm will lead to lower societal cost.
Study design
Cluster randomized design, randomization will take place on hospital level. All
patients will be followed for 2 years.
Intervention
Intervention group: a treatment algorithm has been formulated, based on a
previous performed systematic review, results of recently finished RCT, and an
assigned ACL expert panel. Special attention is given to shared decision making.
Control group (usual care): treatment decision is made based on the experience
of the orthopedic surgeon combined with the preference of the patient.
Study burden and risks
The burden is primarily time (visit of outpatient clinic, and to fill in
questionnaires). There is no direct benefit from participation or group
relatedness.
dr. Molewaterplein 40
Rotterdam 3015 CE
NL
dr. Molewaterplein 40
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: aged 18 year or older, with a complete primary ACL
rupture (confirmed by MRI and physical examination), maximum of 6 weeks of
physical therapy, and willing to comply with the study protocol.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: multi ligament trauma indicated for surgical
intervention, presence of another disorder that affects the activity level of
the lower limb, pregnancy, and insufficient command of 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 |
|---|---|
| CCMO | NL71823.078.19 |