Massive Rotator Cuff TearsNCT05001581
Irreparable Rotator Cuff Tears Treatment. Comparison of Two Methods: With and Without Biceps Tendon Augmentation
A study testing Arthroscopic partial repair of massive rotator cuff tear and Arthroscopic partial repair of rotator cuff with biceps augmentation in people with Massive Rotator Cuff Tears and Rotator Cuff Injuries, run by Saint Lucas Hospital, Poland at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Massive Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain Chronic
- What is being tested?
- Arthroscopic partial repair of massive rotator cuff tear and Arthroscopic partial repair of rotator cuff with biceps augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jan 2019to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previosus surgery
- Imposibility to performed MRI
- Diabetes
- no compliance
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Laprus
Bielsko-Biala, Silesian Voivodeship, 43-309
Hubert M Laprus, MD, +48 691891274, hubert.laprus@gmail.com
About this study
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.
Read the detailed 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
- Being tested
- Arthroscopic partial repair of massive rotator cuff tear, Arthroscopic partial repair of rotator cuff with biceps augmentation
- Keywords
- Massive rotator cuff, Partial repair, biceps augmentation, shoulder arthroscopy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic partial repair of massive rotator cuff tearProcedure or surgery
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 augmentationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment with biceps augmentation | Active comparator | Complete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis Receives: Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentation |
| Treatment without biceps augmentation | Active comparator | Complete repair of ISP if possible with partial SSP repair and biceps tenotomy Receives: Procedure: Arthroscopic partial repair of massive rotator cuff tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2.5 years
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
Measured: Through study completion, an average of 2.5 years
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.
Measured: Through study completion, an average of 2.5 years
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.
Measured: Through study completion, an average of 2.5 years
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.
Measured: Through study completion, an average of 2.5 years
Secondary outcomes (2)
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.
Measured: Through study completion, an average of 2.5 years
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.
Measured: Through study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start30 Jan 2019
- Primary completion1 Jan 2023 (estimated)
- Study completion20 Feb 2023 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 different groups. Differences in type of surgery Comparison of two ways of treatment
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Lucas Hospital, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hubert Laprus, Saint Lucas Hospital, Poland
- Investigators
- Roman Brzoska, Ph.D, MD, Study chair, St Lukes's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001581
- Sponsor's protocol ID
- SLukasH
- Status last verified
- Sep 2022
- First submitted
- 23 Jun 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05001581
- Acronym / sponsor ID
- SLukasH
- Keywords
- Massive rotator cuff, Partial repair, biceps augmentation, shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Saint Lucas Hospital, PolandUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 12 Aug 2021 (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.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 different groups. Differences in type of surgery Comparison of two ways of treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment with biceps augmentation | Active comparator | Procedure: Arthroscopic partial repair of rotator cuff with biceps augmentationComplete repair of ISP if possible with partial SSP repair and biceps augmentation after its tenodesis |
| Treatment without biceps augmentation | Active comparator | Procedure: Arthroscopic partial repair of massive rotator cuff tearComplete repair of ISP if possible with partial SSP repair and biceps tenotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- chronic supraspinatus tear with retraction grade 3 and muscle fatty infiltration ( measured in MRI ) > 3*
- Infraspinatus tear with retraction and fatty muscle degeneration
Key exclusion criteria (4 listed)
- Previosus surgery
- Imposibility to performed MRI
- Diabetes
- no compliance
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 |
|---|---|---|
| Arthroscopic partial repair of massive rotator cuff tearSurgery 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 | Procedure or surgery | Treatment without biceps augmentation |
| Arthroscopic partial repair of rotator cuff with biceps augmentationSurgery 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 | Procedure or surgery | Treatment with biceps augmentation |
Primary outcome
Comparison of improvement in shoulder range of motion
Time frame: Through study completion, an average of 2.5 years
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
Comparison of improvement in shoulder strength
Time frame: Through study completion, an average of 2.5 years
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
Comparison of improvement in shoulder pain in VAS score
Time frame: Through study completion, an average of 2.5 years
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.
Comparison of shoulder function measured in Constant-Murley Score
Time frame: Through study completion, an average of 2.5 years
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.
Comparison of shoulder function measured in SST Score
Time frame: Through study completion, an average of 2.5 years
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.
2 secondary outcomes
Comparison of radiological outcome in Hamada score
Time frame: Through study completion, an average of 2.5 years
Comparison of radiological outcome in Sugaya score
Time frame: Through study completion, an average of 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Roman Brzoska, Ph.D, MD study chair
St Lukes's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic partial repair of massive rotator cuff tear and Arthroscopic partial repair of rotator cuff with biceps augmentation in people with Massive Rotator Cuff Tears and Rotator Cuff Injuries, run by Saint Lucas Hospital, Poland at 1 site in Poland.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hubert Laprus, MD (+48 691 891 274, hubert.laprus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of improvement in shoulder range of motion (time frame: Through study completion, an average of 2.5 years). The study lists 5 primary outcomes in all. 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 27 Oct 2022.