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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Arthroscopic partial repair of massive rotator cuff tear
Arthroscopic partial repair of rotator cuff with biceps augmentation
Sponsored by
Saint Lucas Hospital, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Massive Rotator Cuff Tears focused on measuring Massive rotator cuff, Partial repair, biceps augmentation, shoulder arthroscopy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LaprusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment with biceps augmentation

Treatment without biceps augmentation

Arm Description

Complete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis

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

Outcomes

Primary Outcome Measures

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
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
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 23, 2021
Last Updated
October 25, 2022
Sponsor
Saint Lucas Hospital, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05001581
Brief Title
Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Lucas Hospital, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massive Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain Chronic
Keywords
Massive rotator cuff, Partial repair, biceps augmentation, shoulder arthroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 different groups. Differences in type of surgery Comparison of two ways of treatment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with biceps augmentation
Arm Type
Active Comparator
Arm Description
Complete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis
Arm Title
Treatment without biceps augmentation
Arm Type
Active Comparator
Arm Description
Complete repair of ISP if possible with partial SSP repair and biceps tenotomy
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic partial repair of massive rotator cuff tear
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic partial repair of rotator cuff with biceps augmentation
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of improvement in shoulder range of motion
Description
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
Time Frame
Through study completion, an average of 2.5 years
Title
Comparison of improvement in shoulder strength
Description
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
Time Frame
Through study completion, an average of 2.5 years
Title
Comparison of improvement in shoulder pain in VAS score
Description
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.
Time Frame
Through study completion, an average of 2.5 years
Title
Comparison of shoulder function measured in Constant-Murley Score
Description
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.
Time Frame
Through study completion, an average of 2.5 years
Title
Comparison of shoulder function measured in SST Score
Description
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.
Time Frame
Through study completion, an average of 2.5 years
Secondary Outcome Measure Information:
Title
Comparison of radiological outcome in Hamada score
Description
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.
Time Frame
Through study completion, an average of 2.5 years
Title
Comparison of radiological outcome in Sugaya score
Description
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.
Time Frame
Through study completion, an average of 2.5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert Laprus, MD
Phone
+48 691 891 274
Email
hubert.laprus@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Brzoska, Ph.D, MD
Organizational Affiliation
St Lukes's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Laprus
City
Bielsko-Biala
State/Province
Śląskie
ZIP/Postal Code
43-309
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert M Laprus, MD
Phone
+48 691891274
Email
hubert.laprus@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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