Primary Objective: To explore factors contributing to optimal patient ATR recovery (subjective, functional, imaging)Secondary Objectives: 1. To gain insight into the course of the recovery phase of the ATR via multiple parameters2. To gain insight…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At 3 months the baseline patient and injury information will be collected by
means of a baseline questionnaire and the patient medical file. Patient data
consists of biographical information, anthropometrics, lifestyle factors,
co-morbidities. Injury data concerns etiology and extent and management
applied.
At 3, 6 and 12 months months post injury the following data will be collected:
-Management complication information from patient status
-Subjective: Dutch versions of the Achilles Tendon Total Rupture Score
(ATRS-NL), ) Euroqol-5D (EQ-5D), OSTRC Overuse Injury Questionnaire, Injury
Psychological Readiness Return to Sport Scale (I-PPRS), Tampa Scale of
Kinisiophobia (TSK), Expectations, Motivations and Satisfaction Questionnaire,
Reasons Failed Return to Sport (at 6 en 12 maanden)
-Functional/Clinical: heel-rise test (strength), range of motion (ROM), tendon
length, and single leg hop for distance (at 12 months)
-Imaging: Ultrasound tissue characterisation (UTC)
-Economical: Productivity Cost Questionnaire (iPCQ) and Medical Consumption
Questionnaire (iMCQ)
Secondary outcome
-Recovery complications (e.g re-rupture, infection) (from medical status) and
return to work/sport (from OSTRC Overuse Injury Questionnaire).
Background summary
The Achilles tendon is the strongest and thickest tendon in the human body.
Despite this, the Achilles tendon is the most frequently ruptured tendon. The
etiology of an Achilles tendon rupture (ATR) is usually traumatic but it can be
due to other factors (medications, tendinopathy, hyperthermia, degenerative
change). The ATR has an acute presentation of severe pain. Patients report a
feeling of *being kicked* in the posterior aspect of the distal part of the
affected leg.
The incidence of the ATR is steadily increasing globally. Although the exact
incidence in the Dutch population is unknown, Sode et al. showed that in
Denmark the incidence has steadily increased from 22.1/100,000 in 1991 to
32.6/100,000 in 2002 (4). Recent research in a USA population has shown that
especially in the middle aged (30-50) the ATR is rising, establishing itself as
one of the most common treated injuries by orthopedic surgeons (5). This
increase in incidence is also expected in the Netherlands, especially given the
promotion of and strong emphasis on Healthy Ageing in the Netherlands, the
ageing population and possibly also obesity. Sport participation and exercise
play a major role in ATR development, and hence the expected increased activity
in the scope of the *exercise is medicine* philosophy of the Healthy Ageing
initiative, may establish an increase in incidence.
Despite the confirmed increasing incidence, a clear management consensus for
the ATR is lacking. The guidelines of the American Academy of Orthopedic
Surgeons (AAOS) have a limited or inconclusive recommendation for the role of
imaging, the choice of treatment, and the form of rehabilitation in the
clinical protocol of ATR patients. Additionally, Kolfschoten et al. stated that
there is insufficient scientific evidence to construct a conclusive management
protocol in the Netherlands. Currently, management decisions depend mostly on
the experience of the practitioner who sees the patient first (surgeon or
sports medicine physician). Surgical and conservative treatment are both
supported by literature and the recovery (rehabilitative) phase starts at 3
months post-injury, as recommended bij the AAOS. A recent Systematic Review of
Randomized Controlled Trials (RCTs) by Holm et al. concluded that the
difference in outcome between surgical and conservative treatment of ATRs is
minimal . Because guidelines are inconclusive and RCTs show the difference in
outcome based on primary treatment (surgery or conservative) is not significant.
Furthermore, no research has taken cost-effectiveness into account when
analyzing management options for ATRs. To contribute to an ATR guideline it is
therefore essential to enhance knowledge concerning the optimal management for
the patient but also the public.
Up to now, the used imaging modalities such as ultrasound have no additional
role in ATR recovery monitoring. We plan to examine the potential for an
applicable ATR monitoring device, especially given the increasing emphasis
placed on outcome parameters after the rehabilitative phase. Van Schie et al.
concluded that Ultrasound Tissue Characterisation (UTC) might be useful in
Achilles tendon disorder monitoring. This device quantifies and characterizes
tendon structure itself, and standardizes operator-dependent variables (unlike
conventional ultrasound or MRI). However, van Schie et al. focused solely on
tendinopathy, its value within ATR monitoring remains inconclusive.
Finally, with respect to ATR there is no research concerning the decisions to
return to sport, and a recent systematic review determined only 80% actually
return to sport (10). It is not known if psychological variables are connected
with multiple outcomes (subjective, functional/clinical) in patients with ATR.
The association of such psychological factors, outcome and return to sport in
patients with ATR has to be examined to optimize the rehabilitation process.
This project strives to expand on prior research and create more clarity on
proper ATR management and recovery by examining multiple factors. Recovery will
be assessed through multiple outcomes (subjective, functional/clinical, and
imaging). This study strives to explore optimal management decisions as well as
(barriers to) return to sport for specific patient groups. The
cost-effectiveness of the protocol administered to each patient will
additionally be gathered. The UTC device, which is already being applied in a
clinical research setting in the UMCG, will be used as a measurement of tendon
tissue integrity and quality.
Study objective
Primary Objective:
To explore factors contributing to optimal patient ATR recovery (subjective,
functional, imaging)
Secondary Objectives:
1. To gain insight into the course of the recovery phase of the ATR via
multiple parameters
2. To gain insight into the cost-effectiveness of ATR management
3. To gain insight into (barriers to) return to sport
Study design
Multicenter Exploratory Cohort Research
Study burden and risks
Each patient will be subject to 3 visits in 12 months at their treating
hospital. Every visit will take 40 minutes. The following measurements will be
made:
- We will retrieve injury en management data from the patient's medical file
- We will administer a initial "baseline" questionnaire about patient/injury
data - at 3 months
- We will administer questioannires about the patient recovery - at every visit
- We will perform functional tests - at every visit
- We will administer a UTC analysis - at every visit
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
-Be older than 18 years of age at the time of inclusion
-Have been clinically diagnosed with an Achilles tendon rupture and have been treated less than 3 months ago at the UMCG, Martini Hospital or MCL
-Give written informed consent
Exclusion criteria
-Unable to understand Dutch
-Inability to perform and or understand the tests and/or questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL59714.042.17 |
OMON | NL-OMON29205 |