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The Clinical and Biomechanical Research of the New Arthroscopic Technique for the Treatment of High-grade Dislocation of the Acromioclavicular Joint

NCT ID: NCT04532216

Last Updated: 2020-08-31

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-06-30

Brief Summary

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Acromioclavicular joint dislocation is a common disease in shoulder surgery, which mostly occurs in young and middle-aged patients. Severe acromioclavicular joint dislocations of Rockwood type IV, V, and VI require surgical treatment. Among them, the common clinical type IV and type V severe acromioclavicular joint dislocations are often treated with autologous/allogenous tendon transplantation and coracoclavicular ligament reconstruction under shoulder arthroscopy. Although this minimally invasive surgical method has certain advantages over incision surgery, due to factors such as poor healing after tendon transplantation and failure of coracoclavicular fixation, the recurrence rate of postoperative dislocation is still as high as 30%, which seriously affects the prognosis of patients. Therefore, we proposed a new surgical technique of minimally invasive shoulder arthroscopic coracoclavicular suspension fixation and coracoclavicular ligament residual reconstruction, which aims to strengthen the fixation strength of the coracoclavicular space, promote the healing of the coracoclavicular ligament, and reduce the recurrence rate of postoperative dislocation. To improve postoperative shoulder joint function of patients. This project intends to use non-randomized controlled clinical research and biomechanical research to compare traditional surgical techniques with new microscopic techniques in terms of surgical efficacy, postoperative complications, and internal plant fixation strength to establish the therapeutic advantages of the new technology. Its application and promotion provide important clinical evidence to improve the treatment of severe acromioclavicular joint dislocation in the field of shoulder surgery.

Detailed Description

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Conditions

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Dislocation of the Acromioclavicular Joint

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Group Type EXPERIMENTAL

Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device

Intervention Type PROCEDURE

Arthroscopic-assisted AC joint reconstruction with the TightRope device with allograft augmentation and with the patient in the lateral decubitus position is a method of restoring joint stability

Control group

Group Type OTHER

Traditional surgery

Intervention Type PROCEDURE

Tendon transfer

Interventions

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Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device

Arthroscopic-assisted AC joint reconstruction with the TightRope device with allograft augmentation and with the patient in the lateral decubitus position is a method of restoring joint stability

Intervention Type PROCEDURE

Traditional surgery

Tendon transfer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Consecutive cases of coracoclavicular ligament reconstruction surgery usingTightRope Device With Allograft Augmentation and shoulder arthroscopic reconstruction of coracoclavicular ligament with autologous/allogeneic tendon transplantation.
* Injury type Rockwood type IV and V type severe acromioclavicular joint dislocation
* The time from injury to operation is less than 3 weeks

Exclusion Criteria

* Combined with neurovascular injury
* Previous history of ipsilateral shoulder surgery
* The patient refused to sign the informed consent and participate in the trial
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunyan Jiang

Director of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunyan Jiang

Role: STUDY_CHAIR

Sports Medicine Service, Beijing Jishuitan hospital

Central Contacts

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Zhijun Zhang, M.D.

Role: CONTACT

Phone: +86 15201277648

Email: [email protected]

Other Identifiers

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CJiang

Identifier Type: -

Identifier Source: org_study_id