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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Zhengzhou Orthopaedic Hospital | UNKNOWN |
| Shenzhen Second People's Hospital | OTHER |
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This study intends to perform round-tunnel and flat-tunnel ACL reconstruction technique in 144 patients, and compare the clinical outcomes of the two surgical procedures through follow-up.
This is a prospective randomized, controlled, multi-center clinical trial study on ACL reconstruction surgery technique. It is jointly undertaken by the Peking University Third Hospital, Nanjing Drum Tower Hospital, Zhengzhou Orthopaedic Hospital, and Shenzhen Second People's Hospital. Peking University Third Hospital is the team leader unit. In this study, 144 patients with ACL rupture were recruited according to the enrollment criteria. Among them, 54 patients with ACL rupture were recruited and carried out by the Peking University Third Hospital. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. Each of the other three hospitals recruited 30 patients and randomly grouped them according to the same enrollment criteria. The ratio of the experimental group to the control group was also 1:1. In this study, 72 patients with ACL rupture in the experimental group will be treated with flat-tunnel reconstruction technique, and 72 patients with ACL rupture in the control group will be treated with round-tunnel technique. All operations will be performed with autologous hamstring tendons. After reconstruction, all subjects will participate in the collection of clinical function scores including Tegner score, Lysholm score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis to verify ACL Advantages of flat-tunnel technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | round tunnel |
|
| Experimental group | Experimental | flat tunnel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| round tunnel technique | Procedure | Both the femoral tunnel and tibial tunnel were drilled by 8-mm cannulated drill |
|
| Measure | Description | Time Frame |
|---|---|---|
| KT-2000 | side-to-side difference | 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tegner Score | functional scores | 6 months, 12 months, 24 months |
| Lysholm Score | functional scores | 6 months, 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| flat tunnel technique | Procedure | Both the femoral tunnel and tibial tunnel were dimension of 5×11-mm rounded-rectangular, which was created by initially drilling a round tunnel with a 5-mm cannulated drill and reshaped by use of a bone rasp and custom-made dilator. |
|
| IKDC Score | functional scores | 6 months, 12 months, 24 months |
| Lachman test | physical examination | 6 months, 12 months, 24 months |
| Pivot-shift test | physical examination | 6 months, 12 months, 24 months |