To determine the incidence of linear and angular growth disturbances following ACL reconstruction in patients with open physis.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to determine the incidence of linear and angular
growth disturbances following ACL reconstruction in patients with open physis.
Secondary outcome
Secondary objectives are the PROMS, clinemetrics, complications, failure rate.
And the incidence of growth disturbance plotted against the amount of growth
remaining at the time of ACL surgery and surgical technique. As well as to
determine the incidence of early growth disturbances and the influence of the
estimated residual growth and operative technique on growth disturbances.
Background summary
Anterior cruciate ligament (ACL) injuries in children create a high level of
concern, as the incidence is rising rapidly and the consequences of this injury
are magnificent with reduced activity levels, negative effects on knee-related
quality of life, and risk of premature onset of posttraumatic osteoarthritis.
The limited scientific evidence regarding the potential negative consequences
of ACL reconstruction with an autologous tendon graft in the skeletally
immature patients, is conducted in mostly small cohorts with infrequent use of
the gold standard of radiography. This leads to a variable state of care, and
requires clarification as ACL reconstruction does improve outcome compared to
conservative treatment. In this study we want to determine the incidence of
growth disturbances, to assist the patient and the orthopedic surgeon to make a
more informed decision on the treatment plan.
Study objective
To determine the incidence of linear and angular growth disturbances following
ACL reconstruction in patients with open physis.
Study design
Retrospective cohort study with prospectively collected data.
Study burden and risks
Patients in the first group will be recruited for a one-time outpatient visit
to conduct all outcome measures, including radiographic analysis (bilateral
lateral knee and long-leg radiograph), clinimetrics, self-reported functional
outcomes and history taking regarding failure of ACL reconstruction,
complications and subsequent re-operation . All these outcome measures are
similar to the data collected during current-practice follow-up. Patients in
the second group therefore will be reviewed retrospectively without undergoing
any interventions as part of this study. If the potential risks of ACL
reconstruction does not outweigh the previously established benefits, we might
shift our practice to a more aggressive reconstructive approach in order to
avoid the perils of conservative treatment.
Geerdinksweg 141
Hengelo 7555 DL
NL
Geerdinksweg 141
Hengelo 7555 DL
NL
Listed location countries
Age
Inclusion criteria
- Proven primary ACL rupture, confirmed by means of history, physical
examination and magnetic resonance imaging (MRI) for which ACL reconstruction
with an autologous tendon graft was performed
- Open physis at time of surgery, based on the pre-operative radiograph
- Minimum follow-up of 1 year
- 16 years or older at the time of recruitment for the present study (only
applicable to group 1)
- 12 years or older at the time of recruitment for the present study (only
applicable to group 2)
Exclusion criteria
- Unable to understand Dutch language
- Contralateral ACL rupture, with open physis at time of ACL reconstruction
- Multiligamentous injury (lateral or medial collateral ligament > grade 2,
posterior cruciate ligament > grade 1)
-Under 16 years of age at time of prospective data collection (only applicable
to group 1)
-Under 12 years of age at time of retrospective data collection (only
applicable to group 2)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84000.100.23 |