Rotator Cuff Injuries, Rotator Cuff Tears, Stem Cells
Conditions
Keywords
Adipose derived stem cells, ADSC
Brief summary
The aim of the project is to investigate whether repeated implantations of micro-fragmented adipose tissue (MFAT), into the shoulder muscle can improve the outcome of standard surgical treatment for rotator cuff tears (RCT). The investigators hypothesize that combining surgery with repeated implantations of micro-fragmented adipose tissue (MFAT) into the muscle provides a more effective treatment for patients with rotator cuff tears compared to standard surgical treatment. The result would be better outcomes such as improved shoulder functioning and reduced pain.
Detailed description
Treatment of RCTs with micro-fragmented adipose tissue is a minimal invasive procedure with the potential to shorten recovery, accelerate return to daily activity and work and improve functional outcomes compared to conventional surgery alone. This study will provide evidence on whether three MFAT injections can augment conventional rotator cuff tear treatment. It will also assess the feasibility of implementing this treatment as part of standard care, given its potential for easy standardization. In addition to offering a novel therapeutic approach, the project will correlate functional outcomes with data from muscle biopsies, phenotypic composition of the implanted cells, imaging modalities, and patient reported outcomes. This study will generate critical new knowledge and serve as a cornerstone for the development of precision regenerative medicine in shoulder pathology. By elucidating patient-specific biological responses and therapeutic outcomes, the investigators aim to advance personalized treatment strategies for rotator cuff tears. Building on these findings, we aim to launch a clinical trial to further validate precision medicine as a standard therapeutic approach for patients suffering from rotator cuff tears.
Interventions
BIOLOGICALAdipose derived stem cell injection
A total of 5 mL of the stem cell suspension is injected into the supraspinatus muscle at three predefined sites located at the musculotendinous junction. For each site, 1.5-2.0 mL of the suspension is administered using an 18-gauge syringe. Adipose derived stem cell injections for the triple injection will be repeated at 4 and 8 weeks postoperatively. These follow-up treatments will be performed in an outpatient clinic.
BIOLOGICALPlacebo
Standard care
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Clinical signs and symptoms compatible with a traumatic RCT * MR verified supraspinatus tear * Reparable lesion with tendon retraction \< 2 cm. * Fatty infiltration level 0-2 according to Fuchs or out of 5 based on Goutalliers classification * No history of inflammatory disease * Negative infectious disease marker tests Signed consent to the study
Exclusion criteria
* Former surgery in the affected shoulder * Signs of infection * Immunosuppression (due to clinical condition or medical therapy) * Any malignancy within 5 years prior to screening * Previous radiotherapy to the shoulder * BMI under 18 * BMI above 35 * Allergy to antibiotics such as penicillin * Coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Oxford Shoulder Score (OSS) | Baseline and 12 months | The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Oxford Shoulder Score (OSS) at 3 months | Baseline and 3 months | The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst). |
| Change in the Oxford Shoulder Score (OSS) at 6 months | Baseline and 6 months | The Oxford Shoulder Score (OSS) is a 12-item, patient-reported questionnaire designed to measure pain and functional impairment in patients with shoulder pain. It assesses symptoms over the past four weeks, with a modified scoring method (0-4 per question) totaling 0-48 (48 being the best, 0, worst). |
| Change in Quality of Life at 3 months | Baseline and 3 months | Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health. |
| Change in Quality of Life at 6 months | Baseline and 6 months | Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health. |
| Change in Quality of Life at 12 months | Baseline and 12 months | Quality of life will be measured using the EQ5D questionaire, a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This scale is numbered from 0 to 100. 100 = best health and 0 = worst health. |
| Change in Radiological healing at 3 months | Baseline and 3 months | Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. |
| Change in Radiological healing at 6 months | Baseline and 6 months | Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. |
| Change in Radiological healing at 12 months | Baseline and 12 months | Defined as the distance between the bone and the tendon (distance of the gap) measured in millimeters. Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. |
| Change in infiltration with Goutallier at 6 months | Baseline and 6 months | Infiltration of muscle tissue by fat measured according to Goutallier classification. This classification is a five grade scale. Grade 0: normal muscle Grade 1: Some fatty streaks Grade 2: Less than 50% fatty muscle atrophy Grade 3: 50% muscle atrophy Grade 4: More than 50% fatty muscle atrophy |
| Change in infiltration with Goutallier at 12 months | Baseline and 12 months | Infiltration of muscle tissue by fat measured according to Goutallier classification. This classification is a five grade scale. Grade 0: normal muscle Grade 1: Some fatty streaks Grade 2: Less than 50% fatty muscle atrophy Grade 3: 50% muscle atrophy Grade 4: More than 50% fatty muscle atrophy |
| Change in infiltration with Fuchs at 6 months | Baseline and 6 months | Infiltration of muscle tissue by fat measured according to Fuchs classification. This classification is a three grade scale. Grade 0: normal muscle or some fatty streaks Grade 1: less than 50% fatty muscle atrophy Grade 2: 50% or more muscle atrophy |
| Change in infiltration with Fuchs at 12 months | Baseline and 12 months | Infiltration of muscle tissue by fat measured according to Fuchs classification. This classification is a three grade scale. Grade 0: normal muscle or some fatty streaks Grade 1: less than 50% fatty muscle atrophy Grade 2: 50% or more muscle atrophy |
| Change in the range of pain free movement at 3 months | Baseline and 3 months | Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient |
| Change in the range of pain free movement at 6 months | Baseline and 6 months | Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient |
| Change in the range of pain free movement at 12 months | Baseline and 12 months | Clinical healing is defined as pain-free movement about shoulder level, clinically measured by an experienced physician post surgery by the use of strength test equipment. The strength is measured against resistance and in kilos from the arm in a horizontal plane anterior to the patient |
| Change in muscle contraction at 6 months | Baseline and 6 months | Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. The measurement will be recorded during gradual, controlled loading |
| Change in muscle contraction at 12 months | Baseline and 12 months | Using speckle tracking ultrasound (STU), the muscle contraction expressed as deformation of the muscle tissue (muscle strain) will be recorded. Muscle contractility is a direct indicator of functional recovery and STU assessments. The measurement will be recorded during gradual, controlled loading |
Contacts
CONTACTStephanie Wej Andkjær
CONTACTLars Frich
PRINCIPAL_INVESTIGATORLars Frich
Orthopedic research department, Hospital Sønderjylland
Outcome results
None listed