Condition category
Injury, Occupational Diseases, Poisoning
Date applied
02/02/2009
Date assigned
13/03/2009
Last edited
13/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.uoi.gr

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

Publication citations

Additional files

Editorial Notes