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
Scientific
University of Ioannina
Medical School
OAKI
Georgiou Papandreou 2
Ioannina
45221
Greece
| oaki@cc.uoi.gr |
Study information
| Study design | Observational prospective comparative case-series, single-centre |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 10/08/2005 |
| Completion date | 10/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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
45221
Greece
Sponsor information
University of Ioannina (Greece)
University/education
University/education
Medical School
P.O. Box 1186
Ioannina
45110
Greece
| Website | http://www.uoi.gr |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
