Clinical trial NCT05214651: A Clinical Research on Repair of Massive-large Rotator Cuff Tears
Official title: A Clinical Research on Arthroscopic Repair of Massive-large Rotator Cuff Tears With a Novel Inner Fixation Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: novel double row technique
suture bridge double row technique
massive-large rotator cuff tears
retear rate
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 52
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed as a randomized controlled trial, a total of 52 participants with large - massive rotator cuff tears will be prospectively enrolled and randomly divided into 2 groups according to the applied repairing technique: novel double row technique group and suture bridge double row technique group. The functional outcome was measured at the preoperatively, 3, 6, 12 and 24 months postoperatively, using the visual analog scale (VAS) for pain, active and passive ROM, Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California Los Angeles shoulder score (UCLA). The anatomic outcome was evaluated using magnetic resonance imaging at 3, 6, 12 and 24 months postoperatively. The clinical results were compared between the novel double row technique group and suture bridge double row technique group.

Detailed description: The purpose of this study is to compare a novel double row technique with suture bridge double row technique in the arthroscopic repair of massive-large rotator cuff tears clinically. The study is designed as a randomized controlled trial. A total of 52 participants with large - massive rotator cuff tears will be prospectively enrolled and randomly divided into 2 groups according to the applied repairing technique: novel double row technique group and suture bridge double row technique group.

The investigators prospectively enrolled participants who met the following inclusion criteria: preoperative magnetic resonance imaging (MRI) diagnosis of a large - massive sized rotator cuff tear (\>3cm), which was confirmed during operation; chronic tear; older than 17 years and younger than 75 years; without surgical contraindications and willing to participate. The investigators excluded patients with poor quality rotator cuff and irreparable tear; severe glenohumeral arthritis; previous shoulder surgery; accompanied by dislocation or fracture of shoulder; refusal to participate.

Each participant, assigned using a randomization table, was assessed by a clinical researcher, who was blinded to the grouping, at the following time points: preoperatively; 3, 6, 12 and 24 months postoperatively. The visual analog scale (VAS) for pain, active and passive ROM, and functional scores were assessed at each time point. The functional scores including the Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California Los Angeles shoulder score (UCLA). Anatomic healing was evaluated using MRI at 3, 6, 12 and 24 months postoperatively. An experienced musculoskeletal radiologist interpreted the MRI and determined the healing failure rate. On the basis of the MRI findings, type IV or V of the Sugaya classification was regarded as healing failure.

Based on the previous study, the retear rate of large to massive rotator cuff tears treated with suture bridge double row technique was assumed to be 28.3%. Based on the investigators' previous clinical data on large to massive rotator cuff tears, it is assumed that the retear rate of large to massive rotator cuff tears treated with novel double row technique is 1.0%.

Differences in primary end points between the two groups were analyzed using chi-square tests. Set α=0.05, power is 0.80, the sample ratio of the two groups was 1:1. The sample size was estimated with PASS 15.0. A total of 46 patients, with 23 in each group, had sufficient power to detect statistical differences between groups. In consideration of the uncertainty of the effect and the possible loss of follow-up, the design effect was assumed to 10%. Therefore, the total sample size of this study should be more than 46÷90%≈51. To facilitate randomization, the sample size was determined to be 52 patients, with 26 patients in each group.

Variables such as age, sex, tear size, and functional scores were analyzed, and their mean values were obtained. Continuous data were presented as the mean ± SD, and were analyzed using the independent t test. The retear rates between the two groups were analyzed using chi-square tests. Differences in values between the 2 groups were set at P \< .05 to be statistically significant. All statistical analyses were performed using SPSS version 15.0

Eligibility criteria: Inclusion Criteria:

* preoperative magnetic resonance imaging (MRI) diagnosis of a large - massive sized rotator cuff tear (\>3cm), which was confirmed during operation
* chronic tear
* older than 17 years and younger than 75 years
* without surgical contraindications and willing to participate

Exclusion Criteria:

* poor quality rotator cuff and irreparable tear
* severe glenohumeral arthritis
* previous shoulder surgery
* accompanied by dislocation or fracture of shoulder
* refusal to participate

Primary outcomes:
measure: The retear rate of large to massive rotator cuff tears
timeFrame: The incidence of retear during 24 months postoperatively
Secondary outcomes:
measure: functional scores of the shoulder
timeFrame: functional scores of the shoulder were assessed at following time points: preoperatively; 3, 6, 12 and 24 months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Institute of Sports Medicine, Peking University Third Hospital
name: Ping Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: