Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation

Massive and Irreparable Rotator Cuff Tears Treated by Arthroscopic Partial Repair and Partial Repair With Long Head of the Biceps Tendon Augmentation. Comparison of Clinical and Radiological Findings

Management of massive rotator cuff tears (MRCT) is associated with high rates of failure. The long head of the biceps tendon augmentation (LHBTA) by reinforcement of the reconstruction and additional blood supply may improve healing and provide better outcome than partial repair only.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Injuries; Shoulder Pain Chronic; Massive Rotator Cuff Tears
• Intervention / Treatment: Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation; Procedure: Arthroscopic partial repair of massive rotator cuff tear

Detailed Description

Patients with irreparable supraspinatus muscle (SSP) tear, and complete infraspinatus muscle (ISP) tear are including in the prospective, comparative study. Excluding criteria consist of: problems or previous surgery of contralateral shoulder, subscapularis muscle tear larger than stage 2 by Lafosse classification, uncontrolled diabetes and previous surgery. First group consisting of patients treated by partial cuff repair with LHBTA. Second group is comparative group consisting of patients treated by only partial cuff repair without LHBTA. Group stratification depends on quality of the biceps tendon. In case of good tendon quality - its used for biological augmentation, if it's degenerated- tenotomy of the tendon and only partial repair is performing. Irreparability is defined as SSP ≥ 3 in Goutallier classification and stage 3 in Patte classification what is preoperatively assessed by MRI. Assessment tools consisting of range of motion (ROM), strength measurements in position adequate to assess reconstructing tendons and muscles force, Acromio-humeral index (AHI), Constant, SST, Hamada, and Sugaya scores. Goutallier classification for SSP and ISP and diameter of the teres minor muscle (TMn). Radiological and clinical assessment is performing one year after the surgery

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hubert Laprus, MD; Phone Number: +48 691 891 274; Email: hubert.laprus@gmail.com

Study Locations

• Poland
  • Śląskie
    • Bielsko-Biala, Śląskie, Poland, 43-309
      • Recruiting
      • Laprus
      • Contact: Hubert M Laprus, MD; Phone Number: +48 691891274; Email: hubert.laprus@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Massive and irreparable rotator cuff tear:

• chronic supraspinatus tear with retraction grade 3 and muscle fatty infiltration ( measured in MRI ) > 3*
• Infraspinatus tear with retraction and fatty muscle degeneration

Exclusion Criteria:

• Previosus surgery
• Imposibility to performed MRI
• Diabetes
• no compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment with biceps augmentation; Complete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis	Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation; Surgery relies on arthroscopic reconstruction of the rotator cuff tendons. Because of irreparability of Supraspinatus tendon ( always) and infraspinatus tendon ( sometimes) surgeon performed partial repair to cover humeral head by the tendons and because of good quality of the long head of the biceps tendon, its uses as biological reinforcement of the reconstruction to achieve better clinical and radiological outcome
Active Comparator: Treatment without biceps augmentation; Complete repair of ISP if possible with partial SSP repair and biceps tenotomy	Procedure: Arthroscopic partial repair of massive rotator cuff tear; Surgery relies on arthroscopic reconstruction of the rotator cuff tendons. Because of irreparability of Supraspinatus tendon ( always) and infraspinatus tendon ( sometimes) surgeon performed partial repair to cover humeral head by the tendons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of improvement in shoulder range of motion	Range of motion ( ROM) of every patient is measured preoperatively and postoperatively using goniometer and the result is presented in degrees. Comparision of two methods will be perform to assess better method for ROM improvement	Through study completion, an average of 2.5 years
Comparison of improvement in shoulder strength	Strength will be measured by dynamometer in Kilograms [Kg] by main investigator in external rotation position, flexion, abduction and Jobe test position for every patient at the end of the study. Comparison of two methods will be perform to assess better method for shoulder strength improvement	Through study completion, an average of 2.5 years
Comparison of improvement in shoulder pain in VAS score	Pain is assessed preoperatively and postoperatively using VAS score ( from 0 to 10, when 0 is no pain and 10 is the higher possible pain). Comparison of two methods will be perform to assess better method for shoulder pain reduce.	Through study completion, an average of 2.5 years
Comparison of shoulder function measured in Constant-Murley Score	Function of the shoulder will be assess by Constant Murlay score which describes shoulder function in daily routines: In this score range is 0-100 when 100 is the best result.	Through study completion, an average of 2.5 years
Comparison of shoulder function measured in SST Score	Function of the shoulder will be assess by SST score which describes shoulder function in daily routines: In this score range is 0-100% when 100% is the best result.	Through study completion, an average of 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of radiological outcome in Hamada score	Radiological outcome will be assessed by Hamada score. This score measure shoulder cuff arthropathy ( stage 1-5 when 1 is the best result). For every patient this score will be calculated through study completion and comparison of two methods will be performed.	Through study completion, an average of 2.5 years
Comparison of radiological outcome in Sugaya score	Radiological outcome will be assessed by Sugaya score. This score is used to measure quality of tendon reconstruction in MRI view. Range of points in this score is 1-5 when 1 is the best result. For every patient this score will be calculated through study completion and comparison of two methods will be performed.	Through study completion, an average of 2.5 years

Collaborators and Investigators

• Sponsor: Saint Lucas Hospital, Poland
• Investigators: Study Chair: Roman Brzoska, Ph.D, MD, St Lukes's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2019
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 20, 2023

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: shoulder arthroscopy; Massive rotator cuff; Partial repair; biceps augmentation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain
• Other Study ID Numbers: SLukasH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No