An in-vivo gait analysis of the effect of different femoral tunnel positions in anterior cruciate ligament (ACL) reconstruction on knee rotational movement

ISRCTN ISRCTN59873081
DOI https://doi.org/10.1186/ISRCTN59873081
Secondary identifying numbers N/A
Submission date
02/02/2009
Registration date
13/03/2009
Last edited
13/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anastasios Georgoulis
Scientific

University of Ioannina
Medical School
OAKI
Georgiou Papandreou 2
Ioannina
45221
Greece

Email oaki@cc.uoi.gr

Study information

Study designObservational prospective comparative case-series, single-centre
Primary study designObservational
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn 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
Study objectivesWe 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(s)Scientific Committee of the University Hospital of Ioannina, approved on 26/05/2008
Health condition(s) or problem(s) studiedAnterior cruciate ligament (ACL) rupture and reconstruction, knee injury
InterventionTwenty 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 typeOther
Primary outcome measureThe 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 measuresThe 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 study start date10/08/2005
Completion date10/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants30
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment10/08/2005
Date of final enrolment10/05/2008

Locations

Countries of recruitment

  • Greece

Study participating centre

University of Ioannina
Ioannina
45221
Greece

Sponsor information

University of Ioannina (Greece)
University/education

Medical School
P.O. Box 1186
Ioannina
45110
Greece

Website http://www.uoi.gr
ROR logo "ROR" https://ror.org/01qg3j183

Funders

Funder type

University/education

University of Ioannina (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan