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NCT Number: NCT04710966

Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears

The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Qingdao University

Qingdao, 266000, China

About this study

This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)
  • Failed of conservative treatment for more than 3 months
  • Intraoperative arthroscopic confirmed that the tear was Ellman grade II

Exclusion criteria

  • Previous surgical surgery on the shoulder
  • Articular-side or intratendinous rotator cuff tears
  • Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)
  • Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears
  • The presence of other diseases that affect shoulder function
  • Contraindication to arthroscopic surgery or anesthesia

Treatment and study plan

Arthroscopic Debridement

Procedure

For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.

arthroscopic repair

Procedure

For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.

Primary outcomes

  1. The Visual Analog Scale score

    Time frame: Baseline

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  2. The Visual Analog Scale score

    Time frame: Postoperative 6 months

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  3. The Visual Analog Scale score

    Time frame: Postoperative 12 months

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  4. The Visual Analog Scale score

    Time frame: Postoperative 18 months

    Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  5. Constant-Murray Shoulder score

    Time frame: Baseline

    An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints. Possible scores range from 0 to 100，a higher score means a better result.

  6. Constant-Murray Shoulder score

    Time frame: postoperative 6 months

    An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.

  7. Constant-Murray Shoulder score

    Time frame: postoperative 12 months

    An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.

  8. Constant-Murray Shoulder score

    Time frame: postoperative 18 months

    An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.

  9. American Shoulder and Elbow Surgeon score

    Time frame: Baseline

    The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.

  10. American Shoulder and Elbow Surgeon score

    Time frame: postoperative 6 months

    The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.

  11. American Shoulder and Elbow Surgeon score

    Time frame: postoperative 12 months

    The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.

  12. American Shoulder and Elbow Surgeon score

    Time frame: postoperative 18 months

    The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.

  13. University of California-Los Angeles score

    Time frame: Baseline

    The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.

  14. University of California-Los Angeles score

    Time frame: postoperative 6 months

    The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.

  15. University of California-Los Angeles score

    Time frame: postoperative 12 months

    The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.

  16. University of California-Los Angeles score

    Time frame: postoperative 18 months

    The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.

Secondary outcomes

  1. Grading of rotator cuff integrity

    Time frame: 18 months after surgery

    The integrity of the rotator cuff was assessed by magnetic resonance imaging (MRI) according to a grading criteria, as follows: Grade I and II, sufficient thickness with low or partial high intensity; Grade III, insufficient thickness without discontinuity; Grade IV and V, presence of a minor or major discontinuity.

  2. Grading of muscle atrophy

    Time frame: 18 months after surgery

    Muscular atrophy was assessed on oblique sagittal MRI images using an occupation ratio measured by dividing the supraspinatus muscle's cross-sectional area by that of the supraspinatus fossa on the oblique-sagittal view. When the ratio was between 1.00 and 0.60, the muscle was considered normal or with slight atrophy (Grade I); values between 0.60 and 0.40 indicated moderate atrophy (Grade II); values below 0.40 indicated severe atrophy (Grade III).

  3. Grading of fatty degeneration

    Time frame: 18 months after surgery

    Fatty degeneration in supraspinatus muscle was assessed by magnetic resonance imaging (MRI) according to a grading system with stages 0-4 as follows: grade 0, no fat; Grade 1, thin fatty streaks; Grade 2, heavy fat infiltration, with muscle still pre-dominating; Grade 3, even distribution of fat and muscle; Grade 4, more fat than muscle.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

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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