## Protocol Section
### Identification Module
**NCT ID:** NCT06431191

**Brief Title:** Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture

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

#### Organization Study ID Info
**ID:** luyi
#### Organization
**Class:** OTHER
**Full Name:** Beijing Jishuitan Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-18
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Jishuitan Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Jishuitan Hospital

**Investigator Full Name:** Yi Lu

**Investigator Title:** Director of Sports Medicine Service of Beijing Jishuitan hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Full Rotator Cuff Tear

- Microfracture Procedure

- Double Raw Repair

- Lateral Raw Repair

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** lateral raw repair for full tear rotator cuff combined microfracture procedure

**Intervention Names:**

- Procedure: lateral raw

**Label:** Study group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** double raw repair for full tear rotator cuff combined microfracture procedure

**Intervention Names:**

- Procedure: double raw

**Label:** Control group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Study group

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

**Name:** lateral raw

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** double raw repair for full tear rotator cuff combined microfracture procedure

**Name:** double raw

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** rotator cuff re-tear rate

**Time Frame:** 6, 12, 24 months postoperatively

#### Secondary Outcomes

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

**Measure:** VAS (Visual Analogue Scale)

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

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

**Measure:** ASES(American Shoulder and Elbow Surgeons'Form)

**Time Frame:** 3,6,12,24 months postoperatively

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

**Measure:** Constant score

**Time Frame:** 3,6,12,24 months postoperatively

**Description:** A score used to evaluate the shoulder function

**Measure:** UCLA (University LosAngeles scoring system)

**Time Frame:** 3,6,12,24 months postoperatively

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

**Measure:** SST (simple shoulder test)

**Time Frame:** 3,6,12,24 months postoperatively

**Description:** Use a dynamometer to measure in N

**Measure:** front extension, external rotation and internal rotation strength of shoulder

**Time Frame:** 6,12,24 months postoperatively

**Description:** surgical time, describe with minute

**Measure:** surgical time

**Time Frame:** immediately after the surgery

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

**Measure:** Hospitalization expenses

**Time Frame:** immediately after the patient discharge

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Jishuitan hospital

**State:** Beijing

**Zip:** 100000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012421

- Term: Rupture

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070599

- Term: Shoulder Injuries

- ID: D000013708

- Term: Tendon Injuries

- ID: D000050723

- Term: Fractures, Bone

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M624

- Name: Rotator Cuff Injuries

- Relevance: HIGH

- As Found: Rotator Cuff Tears

- ID: M26370

- Name: Fractures, Bone

- Relevance: LOW

- As Found: Unknown

- ID: M18332

- Name: Fractures, Stress

- Relevance: HIGH

- As Found: Microfracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M602

- Name: Shoulder Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M16479

- Name: Tendon Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000070636

- Term: Rotator Cuff Injuries

- ID: D000015775

- Term: Fractures, Stress

### Misc Info Module

- Version Holder: 2024-05-31
