Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair

Rotator Cuff Injury Clinical Trial

— RCR  

Official title:

Clinical & Radiological Assessment of Rotator Cuff Healing After Single Row Vs. Double Row Rotator Cuff Repair; a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885856
• Other study ID #: 2019-00339; ch19Taha
• Status: Completed
• Start date: April 3, 2019
• Est. completion date: July 22, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to analyse whether there is a difference in clinical and radiological outcomes between single row and double row repair techniques for the treatment of shoulder's rotator cuff tears.

Description:

A tear of the rotator cuff is one of the most common disorders of the shoulder and can have a significant effect on daily activities as a result of a loss of motion and strength. The goal of rotator cuff repair is to treat the patient's current clinical symptoms and improve shoulder function and to prevent the long-term consequences of rotator cuff arthropathy. This project aims at a retrospective analysis of preexisting risk factors for sustaining rotator cuff injury as well as for failing to reach the previous functional level, used surgical technique -either single row repair or double row repair- and its significance for the functional outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• Treated by single row or double row repair technique for shoulder's rotator cuff tears

• Time lapse from injury to surgery ranges from one day to less than 1 year

• Availability of clinical and radiological outcomes from 6 months to 1 year follow up

Exclusion Criteria:

• Massive irreparable tear

• Patient has frozen shoulder

• Chronically retracted tendons and atrophic rotator cuff muscles

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Injury

Intervention

Other:
• single row repair technique
single row repair technique
• double row repair technique
double row repair technique

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in The American Shoulder and Elbow Surgeons Shoulder Score (ASES)	The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain ( Visual Analogue Scale ranging from 0 = "no pain at all" to 10 = "pain as bad as it can be"), instability, and activities of daily living (ranging from "unable to do" to " not difficult"). The pain and functional portions are summed to obtain the final ASES score with higher scores indicating better outcomes.	At six months and one year follow up after surgery
Other	Pain at rest (yes/no)	Pain at rest (yes/no)	At six months after surgery
Other	Change in Constant-Murley score (CMS)	Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function	At six months and one year follow up after surgery
Other	Pain at rest (yes/no)	Pain at rest (yes/no)	At one year follow up after surgery
Other	Pain under stress (yes/no)	Pain under stress (yes/no)	At six months after surgery
Other	Pain under stress (yes/no)	Pain under stress (yes/no)	At one year follow up after surgery
Other	Number of Reoperations (quantity)	Number of Reoperations (quantity)	Summarized over a one year follow up period after surgery
Other	Number of Rehospitalizations (quantity)	Number of Rehospitalizations (quantity)	Summarized over a one year follow up period after surgery
Primary	Radiologic assessment of surgical treatment of rotator cuff tear	X-ray shoulder for assessment of acromiohumeral space and morphology (Millimeters)	directly postoperative (within 24 hours after surgery)
Primary	Magnetic resonance imaging (MRI) of surgical treatment of rotator cuff tear	MRI shoulder to asses morphology of shoulder	directly postoperative (within 24 hours after surgery)
Primary	Ultrasonography of surgical treatment of rotator cuff tear	Ultrasonography to evaluate the healing of the tendon at the bone interface and degree of gap Formation (degree)	From 6 months up to 1 year postoperative
Secondary	Active range of motion	Active range of motion of shoulder (degrees)	At six months and one year follow up after surgery
Secondary	Passive range of motion	Passive range of motion of shoulder (degrees)	At six months and one year follow up after surgery
Secondary	Use of analgesics	Use of analgesics (yes/no)	At six months after surgery
Secondary	Use of analgesics	Use of analgesics (yes/no)	At one year follow up after surgery