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

NCT05001581 | Unknown

• 1 other identifier: SLukasH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Massive Rotator Cuff Tears; Rotator Cuff Injuries; Shoulder Pain Chronic

Keywords

Massive rotator cuff; Partial repair; biceps augmentation; shoulder arthroscopy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Comparison of radiological outcome in Hamada score

  Through study completion, an average of 2.5 years

• Comparison of radiological outcome in Sugaya score

  Through study completion, an average of 2.5 years

Study Arms (2)

Treatment with biceps augmentation

ACTIVE COMPARATOR

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

Treatment without biceps augmentation

ACTIVE COMPARATOR

Complete repair of ISP if possible with partial SSP repair and biceps tenotomy

Procedure: Arthroscopic partial repair of massive rotator cuff tear

Interventions

Arthroscopic partial repair of massive rotator cuff tear PROCEDURE

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

Treatment without biceps augmentation

Arthroscopic partial repair of rotator cuff with biceps augmentation PROCEDURE

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

Treatment with biceps augmentation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Lucas Hospital, Poland: lead

Study Sites (1)

Laprus

Bielsko-Biala, Silesian Voivodeship, 43-309, Poland

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Roman Brzoska, Ph.D, MD

  St Lukes's Hospital

  STUDY CHAIR

Central Study Contacts

Hubert Laprus, MD

CONTACT

+48 691 891 274; hubert.laprus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hubert Laprus, MD, Principal investigator. Department of Orthopaedic Surgery

Model Details: 2 different groups. Differences in type of surgery Comparison of two ways of treatment

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 12, 2021
• Study Start: January 30, 2019
• Primary Completion: January 1, 2023
• Study Completion: February 20, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)