Clinical trial NCT03511547: Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
Official title: Arthroscopic Rotator Cuff Reconstruction With or Without Biologic or Synthetic Patch Augmentation in Patients Over 60 Years: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.

Detailed description: An arthroscopic rotator cuff repair is nowadays mostly implemented in order to restore function and reduce or eliminate pain. The primary objective of this randomized controlled trial is to demonstrate, in patients 60 years or older with a large rotator cuff tear, that biological or synthetic patch augmen-tation in arthroscopic rotator cuff repair results in decreased rate of retear 24 months post-operatively compared to re-pair without patch augmentation.

Eligibility criteria: Inclusion Criteria:

* Rotator cuff tear \> 2 cm in the sagittal plane involving the supraspinatus tendon as well as at least the superior 1/3 of the infraspinatus tendon
* Indicated for surgical reconstruction by arthroscopy
* Patient aged 60 years and over
* Consenting participation in this study by signing the Informed Consent form

Exclusion Criteria:

* Osteoarthritis (grade ≥ 2 after Samilson \& Prieto)
* Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
* Tear of the subscapularis \> Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
* Irreparable tear of the supraspinatus
* General medical contraindication to surgery
* Known hypersensitivity to the materials used
* Revision operations
* Open reconstruction
* Tendon transfer necessary (latissimus dorsi or pectoralis major)
* Any disease process that would preclude accurate evaluation including:

  * Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
  * Inadequate blood flow or neuromuscular disease in the affected arm
* Recent history of substance abuse
* Legal incompetence
* German language barrier to complete the questionnaires or
* Participation in any other medical device or medicinal product study that could influence the results of the present study

Primary outcomes:
measure: Occurrence of retear
timeFrame: 24 months
Secondary outcomes:
measure: Pain level (NRS)
timeFrame: 6/24 months
measure: Range of motion (flexion, abduction, external and internal rotation)
timeFrame: 6/24 months
measure: Shoulder strength in 90° abduction and in external rotation (0° abduction)
timeFrame: 6/24 months
measure: Constant Murley Score (CS)
timeFrame: 6/24 months
measure: Oxford Shoulder Score (OSS)
timeFrame: 6/24 months
measure: Subjective shoulder value (SSV)
timeFrame: 6/24 months
measure: Quality of life (utilities) and general health using EQ-5D-5L
timeFrame: 6/24 months
measure: Subjective improvement, expectation, satisfaction with treatment
timeFrame: 6/24 months
measure: Adverse events / complications
timeFrame: 3/6/24 months and intra-operative
Other outcomes:
Locations:
Study officials:
affiliation: Schulthess Klinik
name: Markus Scheibel, Prof
role: PRINCIPAL_INVESTIGATOR
References: