The specific aim of this research project is to measure the tibiofemoral kinematics during in vivo weight bearing lunges of patients at two time points: (1) prior to ACL reconstruction with or without LET, and (2) six months after ACL reconstruction…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To describe the anterior-posterior translation, internal-external rotation and
medial-lateral translation as a function of flexion and knee state (intact
contralateral control, ACL deficient, ACL reconstructed with LET, and ACL
reconstructed without LET).
Secondary outcome
Patient related outcome measurements (PROMs) through validated questionnaires:
IKDC, KOOS, Tegner, anchor questions.
Background summary
Even the most recent anterior cruciate ligament (ACL) reconstruction techniques
remain unable to fully restore normal knee joint biomechanics to normal. The
key to restoring better knee kinematics in ACL surgery lies in understanding
the structures that are damaged in addition to the ACL. Previous studies have
shown that anterolateral extra-articular structures (ALES) may be injured
during initial ACL injury of the knee. Failure to recognize and manage these
concomitant injuries might result in persistent postoperative anterolateral
rotatory instability of the knee, increased forces through the ACL graft and
eventually lead to failure of the primary ACL reconstruction. Concomitant
lateral extra-articular tenodesis (LET) to the ACL reconstruction might be able
to restore the kinematics of the knee. However, no in vivo information on the
combined ACL with LET exists.
Study objective
The specific aim of this research project is to measure the tibiofemoral
kinematics during in vivo weight bearing lunges of patients at two time points:
(1) prior to ACL reconstruction with or without LET, and (2) six months after
ACL reconstruction with or without LET using a combined dual fluoroscopic and
magnetic resonance (MR) imaging technique, with the healthy contralateral knee
as control.
Study design
This study is a randomized clinical trial, consisting of 52 patients with 6
months follow-up. The ACL injured patients will be evenly randomized into two
groups of 26 patients. One group will be reconstructed with the ACL
reconstruction with LET and the other group of patients will be reconstructed
with solely ACL reconstruction.
Patients will be tested two times through weight bearing lunges. *Test 1*,
prior to the ACL reconstruction: MR imaging of both knees i.e. the injured and
healthy contralateral knees, and dual fluoroscopic imaging of both the injured
and healthy contralateral knees. *Test 2*, six months after ACL surgery with or
without LET: dual fluoroscopic imaging of the operated knees, no additional MR
imaging will be made.
Intervention
na
Study burden and risks
For the purpose of this study one extra MR-scan will be made of the healthy
contralateral knee (20min); two dual fluoroscopic imaging studies will be used
to evaluate the tibiofemoral kinematics (30min/study). However, the total
amount of radiation is within the acceptable health standards and is lower than
the natural background radiation and the annual allowed radiation exposure. All
patients whom have ACL surgery in our hospital are asked to fill out
standardized questionnaires (IKDC, KOOS, Tegner, anchor questions). These
questionnaires will be used to analyze the patient related outcome measures
(PROMs).
Bronovolaan 5
DEN HAAG 2597 AX
NL
Bronovolaan 5
DEN HAAG 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Age: 18-40 years
Acute ACL deficient knees (<6 months from injury)
Lachman test 3+ (i.e. > 10-mm translation) on clinical examination
Pivotshift test grade III on clinical examination (i.e. implying anterolateral extra-articular structures are insuffisient)
Scheduled for ACL surgery
Written informed consent
Exclusion criteria
Collateral ligaments injury that requires surgery
Evident cartilage lesions
Injury to underlying bone
Injury or prior surgery to the contralateral knee
Pregnant patients
Patients unable to have MR
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL54848.098.15 |
Other | nog niet bekend |