N/A
N=330
Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Rupture · Deficiency of Anterior Cruciate Ligament · Chronic Instability of Knee · Anterior Cruciate Ligament Injury
Bottom Line
View on ClinicalTrials.gov: NCT00529958 ↗Enrolled (actual)
330
Serious AEs
0.9%
Results posted
Feb 2019
Primary outcome: Primary: Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome — 27.0; 29.8; 28.7; 47.7 Score (0 to 100) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patellar Tendon (Procedure); Hamstring Tendon (Procedure); Double-Bundle (Procedure)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of Calgary
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome |
27.0; 29.8; 28.7; 47.7; 52.6; 50.5 | <0.05 sig |
| SECONDARY Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures |
91; 81; 79; 3; 7; 7 | — |
| SECONDARY Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade |
0; 0; 0; 1; 4; 5 | — |
| SECONDARY Mean International Knee Documentation Committee (IKDC) Subjective Score |
50.1; 51.0; 51.5; 60.2; 65.7; 63.1 | — |
| SECONDARY Number of Participants With Each Pivot Shift Grade |
0; 1; 0; 6; 6; 9 | — |
| SECONDARY Proportion of Patients With Moderate or Severe Kneeling Pain |
29; 29; 18; 17; 9; 4 | — |
| SECONDARY Knee Laxity as Measured by the KT Arthrometer |
4.9; 5.0; 5.1; 1.9; 2.8; 2.8 | — |
| SECONDARY Mean Tegner Activity Level |
7.7; 7.9; 7.9; 4.7; 4.8; 5.0 | — |
| SECONDARY Return to Pre-injury Tegner Activity Level |
27; 33; 28; 44; 43; 36 | — |
| SECONDARY Cincinnati Occupational Rating Scale |
36.6; 35.4; 36.3; 34.7; 36.1; 36.4 | — |
| SECONDARY Skin-to-Skin Operative Times |
75.3; 67.8; 88.0 | — |
| SECONDARY Radiographic (X-ray) Changes |
— | — |
Summary
The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.
Eligibility Criteria
Inclusion Criteria
A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following:
- History of a traumatic injury episode
- Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)
- A positive pivot shift test
- X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required)
- Age 14-50 years old
Exclusion Criteria
- Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. 1 cm ² [61]
- Previous ligament surgery on the affected or contralateral knees
- Cases involving litigation or Worker's Compensation
- Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans)
- X-ray showing that tibial physis is not fused
Data sourced from ClinicalTrials.gov (NCT00529958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.