A Clinical Trial of Precise Positioning and Intelligent Operation of Surgical Robots to Reconstruct Cruciate Ligaments

NCT ID: NCT04980183

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-05-01

Brief Summary

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30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. Experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. Control group will be treated with conventional reconstruction. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

Detailed Description

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In this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. Patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. All subjects will undergo CT evaluation and clinical function evaluation. This project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

Conditions

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Cruciate Ligament Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arthroscopic surgical robot assisted navigation and positioning for cruciate ligament reconstruction

Patient undergoes cruciate ligament reconstruction with robot-assisted navigation and positioning under arthroscopic surgery

Group Type EXPERIMENTAL

Arthroscopic surgical robot

Intervention Type DEVICE

The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot

Conventional arthroscopic cruciate ligament reconstruction

The patient undergoes conventional arthroscopic cruciate ligament reconstruction

Group Type ACTIVE_COMPARATOR

Conventional arthroscopic cruciate ligament reconstruction

Intervention Type DEVICE

The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment

Interventions

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Arthroscopic surgical robot

The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot

Intervention Type DEVICE

Conventional arthroscopic cruciate ligament reconstruction

The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18-45 years old, with closed epiphyses;
2. For the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the Outerbridge injury score is ≤ II;
3. There is no history of trauma or fracture of the ipsilateral knee joint;
4. The medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree I).

Exclusion Criteria

1. BMI is less than 18.5 or greater than 35 kg/m2;
2. Patients with moderate or severe knee degeneration;
3. Those with limited flexion angle (\<120 degrees);
4. Cartilage defect area is greater than 2 cm2 or Outerbridge damage score\> Grade II.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingfang Ao, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xin Zhang, Ph.D.

Role: CONTACT

18811332558

Yingfang Ao, Prof.

Role: CONTACT

18811332558

Other Identifiers

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M2021156

Identifier Type: -

Identifier Source: org_study_id

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