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NCT Number: NCT06431191

Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture

This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear.

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Key information

Conditions

Full Rotator Cuff Tear Double Raw Repair Lateral Raw Repair Microfracture Procedure

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Arthroscopy confirmed small to medium full rotator cuff tear
  • Unilateral rotator cuff injury
  • Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
  • Young and middle-aged patients aged 20 to 60

Exclusion criteria

  • Previous shoulder surgery (incision or arthroscopy)
  • Combined with diseases of other parts of the same limb
  • Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
  • Bilateral onset
  • Unable or unwilling to receive clinical follow-up

Treatment and study plan

lateral raw

Procedure

lateral raw repair for full tear rotator cuff combined microfracture procedure, without medial raw

double raw

Procedure

double raw repair for full tear rotator cuff combined microfracture procedure

Primary outcomes

  1. rotator cuff re-tear rate

    Time frame: 6, 12, 24 months postoperatively

    the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon

Secondary outcomes

  1. VAS (Visual Analogue Scale)

    Time frame: 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively

    A score used to evaluate the pain, higher scores mean a worse outcome.

  2. ASES(American Shoulder and Elbow Surgeons'Form)

    Time frame: 3,6,12,24 months postoperatively

    A score used to evaluate the shoulder function, higher scores mean a better outcome.

  3. Constant score

    Time frame: 3,6,12,24 months postoperatively

    A score used to evaluate the shoulder function,higher scores mean a better outcome.

  4. UCLA (University LosAngeles scoring system)

    Time frame: 3,6,12,24 months postoperatively

    A score used to evaluate the shoulder function

  5. SST (simple shoulder test)

    Time frame: 3,6,12,24 months postoperatively

    A score used to evaluate the shoulder function,higher scores mean a better

  6. front extension, external rotation and internal rotation strength of shoulder

    Time frame: 6,12,24 months postoperatively

    Use a dynamometer to measure in N

  7. surgical time

    Time frame: immediately after the surgery

    surgical time, describe with minute

  8. Hospitalization expenses

    Time frame: immediately after the patient discharge

    payment during the hospital stay, Treatment fee is calculated in RMB

Sponsors and collaborators

Lead sponsor

Beijing Jishuitan Hospital

Other

Registry information

Official study title

Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture in Small to Medium Size Rotator Cuff Tear

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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