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
Protocol serial number	N/A
Sponsor	University of Ioannina (Greece)
Funder	University of Ioannina (Greece)

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

Primary study design	Observational
Study design	Observational prospective comparative case-series, single-centre
Secondary study design	Other
Study type	Participant information sheet
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
Study objectives	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(s)	Scientific Committee of the University Hospital of Ioannina, approved on 26/05/2008
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	10/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	30
Key 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
Key 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)
Date of first enrolment	10/08/2005
Date of final enrolment	10/05/2008

Locations

Countries of recruitment

Greece

Study participating centre

University of Ioannina

Ioannina
45221
Greece

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes