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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Laprus | Bielsko-Biala | Slaskie |
Lead Sponsor | Collaborator |
---|---|
Saint Lucas Hospital, Poland |
Poland,
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 |
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