Massive Rotator Cuff TearsAMRISNCT04571918
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
A study testing Biodegradable spacer and Debridement and biceps tenotomy in people with Massive Rotator Cuff Tears, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Massive Rotator Cuff Tears
- What is being tested?
- Biodegradable spacer and Debridement and biceps tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Nov 2020to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification.
- Persistent pain for at least 3 months, with documented failure of conservative treatment
- Age ranging from 60 years of age to 85 years of age
Who cannot join
- Significant shoulder osteoarthritis in the affected shoulder, Hamada classification >2.
- Total rupture of subscapularis tendon and/or teres minor, classified B and E in the Collins classification.
- Comorbidity to the degree that the patient will not be able to participate in the follow up program.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway2 sites, 2 recruiting
- Recruiting
Hospital of Southern Norway, Arendal
Arendal, 4848
Hannah U. Jahr, Cand.med, +4790762377, hannahuj@sshf.no
Marek W Zegzdryn, cand.med, +4791143329, marek.walerian.zegzdryn@sshf.no
- Not yet recruiting
Oslo university hospital
Oslo, 0424
Berte Bøe, PhD, +4741338451, uxbebm@ous-hf.no
Ragnhild Støen, PhD, stox@ous.hf.no
About this study
Official title: Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options.
The study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.
Read the detailed description
The study is designed as a double blinded randomized controlled trial. The physiotherapist responsible for the clinical testing and the patient are both blinded. The surgeon knows which group the patient is in but is not responsible for any of the testing. We will randomize with envelopes perioperatively. The participants are randomized in hence "ballon" or "not ballon". In advance of the randomization the surgeon will evaluate if the patient is candidate for partial suture before randomization. We plan to stratify the patients with partial suture to ensure homogeneity between the groups.
The operation will start with arthroscopic debridement and biceps tenotomy in both groups. The patients are thereby evaluated for partial suture and randomized. The insertion of the subacromial spacer is done at the end of the operation for those patients randomized to the group "balloon". Peroperatively the surgeon will classify the grade of osteoarthritis with Outerbridge classification and the state of the rotator cuff and the long head of the biceps tendon.
Postoperative mobilization will be the following:
- 0-2 weeks: Immobilization in a sling. The participant is advised to do simple exercises for shoulder mobilization. Restriction of movement above shoulder level.
- 2-6 weeks: Free mobilization. Advised to avoid heavy lifting.
- 6-12 weeks: Work on increasing range of motion, gradually introduce weight lifting.
- Conditions
- Massive Rotator Cuff Tears
- Being tested
- Biodegradable spacer, Debridement and biceps tenotomy
- Keywords
- Ballon spacer, Biodegradable spacer, Subacromial spacer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodegradable spacerProcedure or surgery
Implantation of a biodegradable balloon used as a subacromial spacer.
Debridement and biceps tenotomyProcedure or surgery
Surgery with arthroscopic debridement and biceps tenotomy
| Study group | Role | What they receive |
|---|---|---|
| Group A: Biodegradable spacer | Experimental | Intervention group Receives: Procedure: Biodegradable spacer; Procedure: Debridement and biceps tenotomy |
| Group B: control group | Active comparator | Control group Receives: Procedure: Debridement and biceps tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Constant score
A well review score that takes several factors in to account: active range of motion, activities of daily living, pain and strength. A person with a normal, healthy shoulder should score 100 points, which is maximum score. Constant score is seen as a relatively objective test, as the testing will be performed by a physiotherapist.
Measured: Preop, 6 months, 1 year, 2 years, 5 years, 10 years.
Secondary outcomes (4)
WORC
Western Ontario Rotator Cuff Index is a questionnaire that explores 5 domains: physical symptoms, sports and recreation, work, social function, emotions.
Measured: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
X-ray of the shoulder
Measure the height from the head of the humerus to the acromion
Measured: Preop. Postop: 1. day, 1 year, 2 years, 5 years, 10 years
VAS
Visual analog scale for pain in rest, activity and at night. Scale from 0 til 10.
Measured: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Eq-5D
Questionaire for daily activity
Measured: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah U. Jahr, Oslo University Hospital
- Investigators
- Hannah Ugletveit Jahr, Cand. med, Study director, Hospital of southern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571918
- Sponsor's protocol ID
- 2019/930
- Acronym
- AMRIS
- Status last verified
- Sep 2020
- First submitted
- 29 Jun 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure anonymization of participants, there is no plan to share individual data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and or Biodegradable Spacer: a Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04571918
- Acronym / sponsor ID
- AMRIS / 2019/930
- Conditions
- Massive Rotator Cuff Tears
- Keywords
- Ballon spacer, Biodegradable spacer, Subacromial spacer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Massive rotator cuff tears are common in the adult population. It is estimated that about 12 % of adults 60 years of age or older suffer from a rotator cuff injury. About 40 % of these injuries are classified as massive rotator cuff tears (MRCT). MRCT propose a great challenge to the affected patient and its doctor. It is a painful condition with few treatment options.
The study aims to investigate the operative treatment for MRCT with the new treatment option proposed by Senecovic. Insertion of a biodegradable balloon as a subacromial spacer has proven promising results so far. To this date there is only small and non-randomized studies on the subject. AMRIS are planning to do a randomized controlled study where group A is treated with arthroscopic debridement, biceps tenotomy and biodegradable spacer, while group B, the control group are treated with arthroscopic debridement and biceps tenotomy.
Detailed description
The study is designed as a double blinded randomized controlled trial. The physiotherapist responsible for the clinical testing and the patient are both blinded. The surgeon knows which group the patient is in but is not responsible for any of the testing. We will randomize with envelopes perioperatively. The participants are randomized in hence "ballon" or "not ballon". In advance of the randomization the surgeon will evaluate if the patient is candidate for partial suture before randomization. We plan to stratify the patients with partial suture to ensure homogeneity between the groups.
The operation will start with arthroscopic debridement and biceps tenotomy in both groups. The patients are thereby evaluated for partial suture and randomized. The insertion of the subacromial spacer is done at the end of the operation for those patients randomized to the group "balloon". Peroperatively the surgeon will classify the grade of osteoarthritis with Outerbridge classification and the state of the rotator cuff and the long head of the biceps tendon.
Postoperative mobilization will be the following:
- 0-2 weeks: Immobilization in a sling. The participant is advised to do simple exercises for shoulder mobilization. Restriction of movement above shoulder level.
- 2-6 weeks: Free mobilization. Advised to avoid heavy lifting.
- 6-12 weeks: Work on increasing range of motion, gradually introduce weight lifting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A: Biodegradable spacer | Experimental | Procedure: Biodegradable spacer, Procedure: Debridement and biceps tenotomyIntervention group |
| Group B: control group | Active comparator | Procedure: Debridement and biceps tenotomyControl group |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from a symptomatic massive rotator cuff tear, with fatty infiltration grade 3 or 4 classified on CT by Goutallier et al, or MRI by Fuchs classification.
- Persistent pain for at least 3 months, with documented failure of conservative treatment
- Age ranging from 60 years of age to 85 years of age
Key exclusion criteria (3 listed)
- Significant shoulder osteoarthritis in the affected shoulder, Hamada classification >2.
- Total rupture of subscapularis tendon and/or teres minor, classified B and E in the Collins classification.
- Comorbidity to the degree that the patient will not be able to participate in the follow up program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodegradable spacerImplantation of a biodegradable balloon used as a subacromial spacer. | Procedure or surgery | Group A: Biodegradable spacer |
| Debridement and biceps tenotomySurgery with arthroscopic debridement and biceps tenotomy | Procedure or surgery | Group A: Biodegradable spacer, Group B: control group |
Primary outcome
Change in Constant score
Time frame: Preop, 6 months, 1 year, 2 years, 5 years, 10 years.
A well review score that takes several factors in to account: active range of motion, activities of daily living, pain and strength. A person with a normal, healthy shoulder should score 100 points, which is maximum score. Constant score is seen as a relatively objective test, as the testing will be performed by a physiotherapist.
4 secondary outcomes
WORC
Time frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
X-ray of the shoulder
Time frame: Preop. Postop: 1. day, 1 year, 2 years, 5 years, 10 years
VAS
Time frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Eq-5D
Time frame: Preop. Postop: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: No. To ensure anonymization of participants, there is no plan to share individual data.
Related trials for Massive Rotator Cuff Tears
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Recruiting
Effects Of Biceps Transposition Without Tenotomy For Augmentation Of Massive Rotator Cuff Repairs
Massive Rotator Cuff Tear
Active, not recruitingObservational study
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Rotator Cuff Tears, Rheumatoid Arthritis Shoulder
Recruiting
Voll Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah Ugletveit Jahr, Cand. med study director
Hospital of southern Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodegradable spacer and Debridement and biceps tenotomy in people with Massive Rotator Cuff Tears, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Ugletveit Jahr, Cand. med. (+47 90762377, hannah.jahr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constant score (time frame: Preop, 6 months, 1 year, 2 years, 5 years, 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.