An interventional study of round tunnel technique and flat tunnel technique in Anterior Cruciate Ligament Rupture, sponsored by Peking University Third Hospital. Status unknown. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-07-08.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's planned enrollment of 144 is above the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
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Exclusion Criteria:
round tunnel
Procedure: round tunnel technique
flat tunnel
Procedure: flat tunnel technique
Both the femoral tunnel and tibial tunnel were drilled by 8-mm cannulated drill
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.
KT-2000
side-to-side difference
Time frame: 6 months, 12 months, 24 months
Tegner Score
functional scores
Time frame: 6 months, 12 months, 24 months
Lysholm Score
functional scores
Time frame: 6 months, 12 months, 24 months
IKDC Score
functional scores
Time frame: 6 months, 12 months, 24 months
Lachman test
physical examination
Time frame: 6 months, 12 months, 24 months
Pivot-shift test
physical examination
Time frame: 6 months, 12 months, 24 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital