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

Rotator Cuff Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001581
• Other study ID #: SLukasH
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: February 20, 2023

Study information

• Verified date: September 2022
• Source: Saint Lucas Hospital, Poland
• Contact: Hubert Laprus, MD
• Phone: +48 691 891 274
• Email: hubert.laprus[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 20, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Poland	Laprus	Bielsko-Biala	Slaskie

Sponsors (1)

Lead Sponsor	Collaborator
Saint Lucas Hospital, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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