Comparison of Anterior Cruciate Ligament Isolated Reconstruction or Combined With Lateral Extra-articular Tenodesis in Knee Laxity, Graft Failure and Patient-reported Outcome Measures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Cruciate Ligament Injuries
- Sponsor
- Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from baseline of sagittal and rotational knee laxity
- Last Updated
- 4 years ago
Overview
Brief Summary
It has been suggested that adding a Lateral Extra-Articular Tenodesis (LEAT) to Anterior Cruciate Ligament (ACL) reconstruction has the advantage of better controlling the rotational laxity. The objective of this study is to compare the the sagittal and rotational knee laxity using the Porto Knee Testing Device (PKTD) - a MRI-compatible arthrometer - at 2 years follow-up (side-to-side and to baseline comparison) in patients that underwent isolated ACL reconstruction (isolated ACL) versus ACL reconstruction combined with LEAT (ACL+LEAT). Patient-reported outcome measures using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and graft failure (re-tear) will also be assessed at 2 years follow-up.
Detailed Description
This study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated ACL reconstruction (control group) or ACL reconstruction combined with lateral extra-articular tenodesis (experimental group). The principal outcome of this work is the sagittal and rotational knee laxity analysis and side-to-side and 2-year improvement. The secondary outcomes include graft failure (re-tears) and the patient-reported outcome measures (KOOS) at 2 years follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •no previous knee surgeries
- •contralateral healthy knee
- •positive pivot-shift (++)
Exclusion Criteria
- •revision ACL surgery
- •ACL reconstruction using allograft or synthetic grafts
- •multi-ligament injury
- •pregnant female
- •other injuries or conditions that may alter the knee function (eg. severe osteoarthritis)
- •requiring concomitant osteotomy
- •requiring concomitant cartilage surgery (other than debridement)
Outcomes
Primary Outcomes
Change from baseline of sagittal and rotational knee laxity
Time Frame: Baseline and 24 months
To assess the post-operative knee sagittal and rotational laxity, we will use the Porto Knee Testing Device (PKTD). We will measure the anterior displacement on the medial and lateral plateaus and internal and external rotation in the lateral and medial plateau. Additionally, these measures will be combined to measure the anterior global translation (anterior translation on lateral + medial plateaus) and the global rotation (internal + external rotation in the lateral plateau).
Secondary Outcomes
- Graft Failure(24 months)
- Change from baseline of Tegner Scale(Baseline, 12 and 24 months)
- Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS)(Baseline, 12 and 24 months)