SLAP LesionNCT03189147
BicepsTenodesis vs. Biceps Debridement in Combined RC Tears and SLAP Lesions
A study testing Biceps Tenodesis and Debridement in people with SLAP Lesion, run by University of Alberta at 1 site in Canada.
Trial summary
The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears simultaneously due to the high likelihood of prolonged postoperative immobilization, stiffness and poor clinical outcomes. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- SLAP Lesion
- What is being tested?
- Biceps Tenodesis and Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2018to 29 Aug 2019
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 35 years of age presenting with a high grade partial-thickness or full-thickness RC tear associated with a degenerative SLAP tear and a normal biceps tendon, confirmed by appropriate imaging, that can be surgically repaired using an arthroscopic approach will be eligible for the study.
Who cannot join
- Subjects presenting with pulley involvement, high grade full-thickness RC tears (>3cm), biceps pathology, previous surgery to the affected shoulder, history of shoulder dislocation, inflammatory disease, or moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4), major shoulder joint trauma, infection, or avascular necrosis will be excluded. Furthermore, those with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent, life expectancy of less than 1 year, who do not speak/read/understand English, have no fixed address or contact, or are unwilling to complete follow-ups will also be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BicepsTenodesis vs. Biceps Debridement in Combined Rotator Cuff (RC) Tears and Superior Labral Anterior to Posterior (SLAP) Lesions: A Randomized Trial
The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears simultaneously due to the high likelihood of prolonged postoperative immobilization, stiffness and poor clinical outcomes. The current standard care interventions include debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears. Simple debridement is a low cost and time-saving procedure that has the advantage of maintaining the anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and time-saving; however, since the LHB is released from its attachment in the shoulder joint, the anatomy is not preserved and results in decreased strength and possible development of a 'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches, but has the advantage of preserving the LHB anatomy and power, and a lower possibility of developing complications. Finally, labral repair has the highest costs and associated surgical time and may lead to increase stiffness after surgery, particularly in patients over 45 years old.
Currently, the standard care of the surgeons involved in this study is to use either debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for their RC tear. Based on the current evidence and current practice in our facility, we aim to compare the efficacy of tenodesis versus debridement in patients with combined RC tear, degenerative labrum (SLAP tears) and a normal biceps tendon.
Read the detailed description
Rotator cuff (RC) tears are the most common source of shoulder pain, disability and discomfort. In fact, RC disease is the most common cause of shoulder pain seen by physicians. It has been estimated that as many as 40% of patients with shoulder pain may have a RC tear. Previous research has shown that 80% of these patients will experience pain, and 40% of patients will experience tear progression (tear becoming larger, more painful, multiple muscle involvement). Therefore, it is no surprise that a substantial proportion of individuals with RC tears do not receive adequate relief from non-operative treatments (physiotherapy, acupuncture, massage therapy, activity/work modification, cortisone injection), and require surgical repair.
Surgical repair has been challenging in this population, since frequently RC tears are associated with concomitant labral lesions such as SLAP (superior labral anterior-posterior) tears that may increase patients' symptoms. Miller and Savoie studied one hundred patients with full-thickness RC tears and determine that 74% had coexisting intra-articular abnormalities, and labral tears were the most common associated pathology. Gartsman et al reported that 60.5% of patients with full-thickness RC tears had coexisting intraarticular abnormalities, with 25 patients (12.5%) having major abnormalities that required surgery, changed postoperative rehabilitation or impacted the expected end result. Snyder et al. 8 reported that 40% of patients with SLAP lesions had associated full- or partial-thickness RC tears.
The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears simultaneously due to the high likelihood of prolonged postoperative immobilization, stiffness and poor clinical outcomes. Therefore, the current standard care interventions include debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears3. Recently, Oh et al. compared simple debridement, biceps tenotomy, and biceps tenodesis for the patients with concomitant RC tear and labral lesions. All concomitant treatments improved patients' symptoms. Simple biceps debridement had the lowest risk of patients developing a 'Popeye' deformity and preserved forearm supination strength. Biceps tenotomy appeared preferable for patients with definite groove tenderness while biceps tenodesis was indicated for patients with groove tenderness, but who wanted to preserve supination strength. However, this study was compromised by low follow-up (72%) within one year and unbalanced groups (i.e.one group had significantly more males). Abbot et al. determined that patients over the age of 45 years treated with arthroscopic RC repair and SLAP debridement had significantly better function, pain relief, and range of motion than those treated with RC repair and simultaneous SLAP repair. A systematic review in 2011 looked at the current evidence for effectiveness of interventions to treat RC tears, and they found limited evidence favoring debridement compared to anchor replacement and suture repair of Type II SLAP tear. Another systematic review in 2014 revised the published data on the surgical treatment of superior labral injuries in patients aged 40 years, including those with concomitant injuries to the RC and they stated that the cumulative evidence supports labral debridement or biceps tenotomy over labral repair when an associated RC injury is present.
The above studies are contradictory likely because studies were heterogeneous in terms of selection as well as assessment periods and outcome measurements performed. Therefore, the question about best practice to treat labral lesions in patients with concomitant RC tears remains unanswered.
Moreover, in previous studies, surgical time and costing with the different approaches were not considered. Simple debridement is a low cost and time-saving procedure that has the advantage of maintaining the anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and time-saving; however, since the LHB is released from its attachment in the shoulder joint, the anatomy is not preserved and results in decreased strength and possible development of a 'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches, but has the advantage of preserving the LHB anatomy and power, and a lower possibility of developing complications. Finally, labral repair has the highest costs and associated surgical time and may lead to increase stiffness after surgery, particularly in patients over 45 years old.
Currently, the standard care of the surgeons involved in this study is to use either debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for their RC tear. Annually, in the Edmonton region, as an estimate from all of the surgeons involved in this study, surgeons perform around 200 of each technique (debridement or biceps tenodesis). Based on the current evidence and current practice in our facility, we aim to compare the efficacy of tenodesis versus debridement in patients with combined RC tear, degenerative labrum (SLAP tears) and a normal biceps tendon.
- Conditions
- SLAP Lesion
- Being tested
- Biceps Tenodesis, Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biceps TenodesisProcedure or surgery
Surgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair
DebridementProcedure or surgery
Surgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair
| Study group | Role | What they receive |
|---|---|---|
| Biceps Tenodesis | Experimental | Patients in this group will received biceps tenodesis intervention to address their labral lesion Receives: Procedure: Biceps Tenodesis |
| Debridement | Active comparator | Patients in this group will received debridement intervention to address their labral lesion Receives: Procedure: Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) in different time points
Pain at rest, sleep and with activity will be measured using an 11-point VAS (0-10), a reliable and valid method of measuring patient-reported pain.
Measured: Baseline, 2-weeks, 6-weeks, 3-months, 6-months and 12-months
Secondary outcomes (1)
Range of Motion
Active and passive ROM assessments of shoulder flexion, abduction, external rotation (90° abduction, 90° elbow flexion), and internal rotation (90° abduction, 90° elbow flexion) will be conducted by the research coordinator for both the affected and unaffected shoulder at baseline and only affected arm on follow-ups.
Measured: Baseline, 6-weeks, 3-months, 6-months and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start15 Jan 2018
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Why it stopped: Due to low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLAP LesionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189147
- Sponsor's protocol ID
- Pro00072759
- Status last verified
- Sep 2021
- First submitted
- 12 Jun 2017
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BicepsTenodesis vs. Biceps Debridement in Combined Rotator Cuff (RC) Tears and Superior Labral Anterior to Posterior (SLAP) Lesions: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03189147
- Acronym / sponsor ID
- Pro00072759
- Conditions
- SLAP Lesion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low recruitment rate
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 16 Jun 2017 (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.
The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears simultaneously due to the high likelihood of prolonged postoperative immobilization, stiffness and poor clinical outcomes. The current standard care interventions include debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears. Simple debridement is a low cost and time-saving procedure that has the advantage of maintaining the anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and time-saving; however, since the LHB is released from its attachment in the shoulder joint, the anatomy is not preserved and results in decreased strength and possible development of a 'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches, but has the advantage of preserving the LHB anatomy and power, and a lower possibility of developing complications. Finally, labral repair has the highest costs and associated surgical time and may lead to increase stiffness after surgery, particularly in patients over 45 years old.
Currently, the standard care of the surgeons involved in this study is to use either debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for their RC tear. Based on the current evidence and current practice in our facility, we aim to compare the efficacy of tenodesis versus debridement in patients with combined RC tear, degenerative labrum (SLAP tears) and a normal biceps tendon.
Detailed description
Rotator cuff (RC) tears are the most common source of shoulder pain, disability and discomfort. In fact, RC disease is the most common cause of shoulder pain seen by physicians. It has been estimated that as many as 40% of patients with shoulder pain may have a RC tear. Previous research has shown that 80% of these patients will experience pain, and 40% of patients will experience tear progression (tear becoming larger, more painful, multiple muscle involvement). Therefore, it is no surprise that a substantial proportion of individuals with RC tears do not receive adequate relief from non-operative treatments (physiotherapy, acupuncture, massage therapy, activity/work modification, cortisone injection), and require surgical repair.
Surgical repair has been challenging in this population, since frequently RC tears are associated with concomitant labral lesions such as SLAP (superior labral anterior-posterior) tears that may increase patients' symptoms. Miller and Savoie studied one hundred patients with full-thickness RC tears and determine that 74% had coexisting intra-articular abnormalities, and labral tears were the most common associated pathology. Gartsman et al reported that 60.5% of patients with full-thickness RC tears had coexisting intraarticular abnormalities, with 25 patients (12.5%) having major abnormalities that required surgery, changed postoperative rehabilitation or impacted the expected end result. Snyder et al. 8 reported that 40% of patients with SLAP lesions had associated full- or partial-thickness RC tears.
The appropriate treatment of labral lesions such as SLAP tears in patients undergoing RC tears repair is controversial. Most surgeons are reluctant to repair RC and SLAP tears simultaneously due to the high likelihood of prolonged postoperative immobilization, stiffness and poor clinical outcomes. Therefore, the current standard care interventions include debridement, biceps tenotomy or tenodesis rather than surgical repair of SLAP tears3. Recently, Oh et al. compared simple debridement, biceps tenotomy, and biceps tenodesis for the patients with concomitant RC tear and labral lesions. All concomitant treatments improved patients' symptoms. Simple biceps debridement had the lowest risk of patients developing a 'Popeye' deformity and preserved forearm supination strength. Biceps tenotomy appeared preferable for patients with definite groove tenderness while biceps tenodesis was indicated for patients with groove tenderness, but who wanted to preserve supination strength. However, this study was compromised by low follow-up (72%) within one year and unbalanced groups (i.e.one group had significantly more males). Abbot et al. determined that patients over the age of 45 years treated with arthroscopic RC repair and SLAP debridement had significantly better function, pain relief, and range of motion than those treated with RC repair and simultaneous SLAP repair. A systematic review in 2011 looked at the current evidence for effectiveness of interventions to treat RC tears, and they found limited evidence favoring debridement compared to anchor replacement and suture repair of Type II SLAP tear. Another systematic review in 2014 revised the published data on the surgical treatment of superior labral injuries in patients aged 40 years, including those with concomitant injuries to the RC and they stated that the cumulative evidence supports labral debridement or biceps tenotomy over labral repair when an associated RC injury is present.
The above studies are contradictory likely because studies were heterogeneous in terms of selection as well as assessment periods and outcome measurements performed. Therefore, the question about best practice to treat labral lesions in patients with concomitant RC tears remains unanswered.
Moreover, in previous studies, surgical time and costing with the different approaches were not considered. Simple debridement is a low cost and time-saving procedure that has the advantage of maintaining the anatomy of the long head of biceps (LHB), a muscle that acts as an active depressor of the head of the humerus in patients with RC tears. Biceps tenotomy is also low cost and time-saving; however, since the LHB is released from its attachment in the shoulder joint, the anatomy is not preserved and results in decreased strength and possible development of a 'Popeye' deformity. Biceps tenodesis has higher costs and time than the other two approaches, but has the advantage of preserving the LHB anatomy and power, and a lower possibility of developing complications. Finally, labral repair has the highest costs and associated surgical time and may lead to increase stiffness after surgery, particularly in patients over 45 years old.
Currently, the standard care of the surgeons involved in this study is to use either debridement or biceps tenodesis to address labral lesions in patients undergoing surgery for their RC tear. Annually, in the Edmonton region, as an estimate from all of the surgeons involved in this study, surgeons perform around 200 of each technique (debridement or biceps tenodesis). Based on the current evidence and current practice in our facility, we aim to compare the efficacy of tenodesis versus debridement in patients with combined RC tear, degenerative labrum (SLAP tears) and a normal biceps tendon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biceps Tenodesis | Experimental | Procedure: Biceps TenodesisPatients in this group will received biceps tenodesis intervention to address their labral lesion |
| Debridement | Active comparator | Procedure: DebridementPatients in this group will received debridement intervention to address their labral lesion |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 35 years of age presenting with a high grade partial-thickness or full-thickness RC tear associated with a degenerative SLAP tear and a normal biceps tendon, confirmed by appropriate imaging, that can be surgically repaired using an arthroscopic approach will be eligible for the study.
Key exclusion criteria (1 listed)
- Subjects presenting with pulley involvement, high grade full-thickness RC tears (>3cm), biceps pathology, previous surgery to the affected shoulder, history of shoulder dislocation, inflammatory disease, or moderate to severe degenerative glenohumeral arthropathy (Kellgren-Lawrence Grade 3 or 4), major shoulder joint trauma, infection, or avascular necrosis will be excluded. Furthermore, those with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent, life expectancy of less than 1 year, who do not speak/read/understand English, have no fixed address or contact, or are unwilling to complete follow-ups will also be excluded
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 |
|---|---|---|
| Biceps TenodesisSurgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair | Procedure or surgery | Biceps Tenodesis |
| DebridementSurgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair | Procedure or surgery | Debridement |
Primary outcome
Change in Visual Analog Scale (VAS) in different time points
Time frame: Baseline, 2-weeks, 6-weeks, 3-months, 6-months and 12-months
Pain at rest, sleep and with activity will be measured using an 11-point VAS (0-10), a reliable and valid method of measuring patient-reported pain.
1 secondary outcome
Range of Motion
Time frame: Baseline, 6-weeks, 3-months, 6-months and 12-months
Results and safety
The study was stopped early (reason given: Due to low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
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Reliability and Accuracy of a New Clinical Test for Biceps Lesions
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biceps Tenodesis and Debridement in people with SLAP Lesion, run by University of Alberta at 1 site in Canada.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Sep 2021. 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 Canada. 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?
The study was stopped early (reason given: Due to low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) in different time points (time frame: Baseline, 2-weeks, 6-weeks, 3-months, 6-months and 12-months). 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 22 Sep 2021.