CClinicalTrials.gg
Status unknownNCT04532216Updated Aug 31, 2020

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

An interventional study of Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device and Traditional surgery in Dislocation of the Acromioclavicular Joint, sponsored by Beijing Jishuitan Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2020-08-31.

Sponsored by Beijing Jishuitan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Sex
All
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Study summary

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.

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Conditions studied

  • Dislocation of the Acromioclavicular Joint

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03

In context

Joint Dislocations

190 studies on the registry are indexed under Joint Dislocations; 39 are open to participants now.

This study's planned enrollment of 54 is close to the median of 53 across 120 interventional studies indexed under Joint Dislocations.

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Lead sponsor

Beijing Jishuitan Hospital is the lead sponsor of 43 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Study group

    Procedure: Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device

  • Other
    Control group

    Procedure: Traditional surgery

Interventions

  • ProcedureArthroscopic-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

  • ProcedureTraditional surgery

    Tendon transfer

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What researchers measure

Primary outcomes

  1. ASES score

    The ASES score is a 10-item measure of shoulder pain and function

    Time frame: 1 year postoperatively

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04532216
Lead sponsor
Beijing Jishuitan Hospital
Responsible party
Chunyan Jiang (Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital) — Principal investigator
First posted
Aug 31, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Jun 30, 2022 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Aug 31, 2020

Study contacts

Zhijun Zhang, M.D.
Contact
zzj5285029@163.com
+86 15201277648
Chunyan Jiang
study chair · Sports Medicine Service, Beijing Jishuitan hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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