Contact information
Type
Scientific
Primary contact
Prof Anastasios Georgoulis
ORCID ID
Contact details
University of Ioannina
Medical School
OAKI
Georgiou Papandreou 2
Ioannina
45221
Greece
oaki@cc.uoi.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An in-vivo gait analysis of the effect of different femoral tunnel positions in anterior cruciate ligament (ACL) reconstruction on tibial rotation: a prospective case-series
Acronym
Study hypothesis
We hypothesised that a more horizontal placement of the anterior cruciate ligament (ACL) substitute graft (at the 10 o'clock position in the femur) can address abnormal rotational knee movement after an ACL reconstruction, as compared to the standard 11 o'clock femoral position.
Ethics approval
Scientific Committee of the University Hospital of Ioannina, approved on 26/05/2008
Study design
Observational prospective comparative case-series, single-centre
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anterior cruciate ligament (ACL) rupture and reconstruction, knee injury
Intervention
Twenty ACL reconstructed subjects (mean age: 28 +/- 8 years) and ten healthy subjects (mean age: 29 +/- 5 years) were enrolled in this study. The ACL reconstructed subjects were tested as follows (on average) 2 years after the surgery.
1. Knee muscle strength measured with BIODEX System-3® (Biodex Corp., USA) isokinetic dynamometer
2. Clinical evaluation:
2.1. Patient's level of activity measured with the Tegner test
2.2. Patient's knee functional scale measured with the Lysholm test
3. Anterior tibial translation was evaluated using the KT-1000™ Arthrometer® (MEDmetric Corp., USA) for both ACL reconstructed subjects and the healthy controls.
4. An eight camera optoelectronic system (Vicon-Peak Performance Technologies, Inc., UK/USA) was used to capture the movements of fifteen reflective markers placed on the selected bony landmarks of the lower limbs and the pelvis of the examined subjects. The subjects were asked to perform two different activities: 1) descending from a stair and subsequent pivoting, and 2) landing from a platform and subsequent pivoting. We also placed inline foot switches (Noraxon Inc., USA) with two sensors on each, on the plantar surface of the shoes in the toe and heel positions. Foot-switch data collection was time-synchronized with the kinematic data through the Vicon-Peak® digital transceiver. The signals provided from the foot-switches were used to determine the exact time occurrences of the start and the end of the pivoting period that was under evaluation. Based on our hypothesis, the dependent variable examined in the present study was the range of motion of tibial rotation during the pivoting period for the two examined tasks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The following were assessed at 2 years after ACL reconstruction:
1. Tibial rotation (kinematics) measured with the gait analysis system
2. Tibial translation measured with KT-1000™ Arthrometer®
3. Patient's level of activity measured with the Tegner test
4. Patient's knee functional scale measured with the Lysholm test
Secondary outcome measures
The following were assessed at 2 years after ACL reconstruction:
1. Knee muscle strength measured with BIODEX isokinetic dynamometer
2. Knee joint stability measured with static tests (Lachman, anterior-drawer, pivot-shift)
Overall trial start date
10/08/2005
Overall trial end date
10/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males
2. Patients with ACL reconstruction with a bone patellar tendon bone (BPTB) graft
3. Healthy subjects
Note: Participants with similar anthropometric features and age group were selected for this study in order to minimise bias
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
30
Participant exclusion criteria
1. Patients with concomitant injuries (e.g., chondral lesions, lateral collateral ligament injuries or meniscal injuries in which a meniscectomy or a suture of the meniscus was performed)
2. Patients with symptomatic anterior knee pain or objective instability at the latest follow-up examination (positive pivot-shift test results, positive Lachman-test results and arthrometer side-to-side differences of more than 3 mm)
Recruitment start date
10/08/2005
Recruitment end date
10/05/2008
Locations
Countries of recruitment
Greece
Trial participating centre
University of Ioannina
Ioannina
45221
Greece
Sponsor information
Organisation
University of Ioannina (Greece)
Sponsor details
Medical School
P.O. Box 1186
Ioannina
45110
Greece
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Ioannina (Greece)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary