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A randomized, single-blind, parallel-controlled, multicenter clinical study to evaluate the safety and efficacy of wire anchors in the treatment of soft tissue injuries at the joint compared with Smith &Nephew Inc. Double fixation screws

A randomized, single-blind, parallel-controlled, multicenter clinical study to evaluate the safety and efficacy of wire anchors in the treatment of soft tissue injuries at the joint compared with Smith &Nephew Inc. Double fixation screws

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051716
Enrollment
Unknown
Registered
2021-10-01
Start date
2017-09-01
Completion date
Unknown
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue injury in rotator cuff joint

Interventions

experimental group:randomized controlled
control group:randomized controlled

Sponsors

Hunan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent; 2. 18 to 75 years old patients (including 18 and 75 years old) of any sex; 3. It the diagnosis of rotator cuff injury and need rotator cuff repair under arthroscope without contraindication; 4. Good compliance, willing and able to follow-up observation as required.

Exclusion criteria

Exclusion criteria: 1) Patients who have participated in other medical device trials within 3 months; 2) Patients with Severe Allergic Constitution; 3) Patients with abnormal liver or kidney function [Sgpt (ALT) or Sgot (AST) or creatinine (CR)] who are 1.5 times higher than the upper limit of the normal value; 4) Patients with severe heart or lung disease who are restricted from participating in the study and can not be followed up or compromise the scientific integrity of the study; 5) Poor compliance, psychosis, mental disorder, difficulty in cooperating; 6) Pregnancy test positive, pregnant or lactating women, recent family planning; 7) Inability to use viable contraception during the trial; 7) Evidence of Substance Abuse; 8) Peripheral nerve injury at the site of Surgery; 9) History of myocardial infarction within 6 months and cerebral infarction within 3 months; 10) History of cervical spondylotic myelopathy or radiculopathy; 11) Other conditions that the researchers considered unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Ucla;

Secondary

MeasureTime frame
MRI;VAS;Measurement of shoulder range of motion;

Countries

China

Contacts

Public ContactJing Wang

Hunan Provincial People's Hospital

18612538111@163.com+86 13973151533

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026