SLAP Lesion Clinical Trial
Official title:
BicepsTenodesis vs. Biceps Debridement in Combined Rotator Cuff (RC) Tears and Superior Labral Anterior to Posterior (SLAP) Lesions: A Randomized Trial
Verified date | September 2021 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 20 |
Est. completion date | August 29, 2019 |
Est. primary completion date | August 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sturgeon Community Hospital | St. Albert | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Shoulder Flexion Strength | Strength assessments will also be conducted by the research coordinator at baseline and 6- and 12-months. Strength will be measured by using peak values of isometric shoulder flexion, using a hand held dynamometer (microFET3, Hoggan Health Industries Inc., West Jordan, UT). | Baseline, 6-months and 12-months | |
Other | Shoulder Abduction Strength | Strength assessments will also be conducted by the research coordinator at baseline and 6-, and 12-months. Strength will be measured by using peak values of isometric shoulder abduction, using a hand held dynamometer (microFET3, Hoggan Health Industries Inc., West Jordan, UT). | Baseline, 6-months and 12-months | |
Other | Shoulder External Rotation Strength | Strength assessments will also be conducted by the research coordinator at baseline and 6-, and 12-months. Strength will be measured by using peak values of isometric shoulder external rotation, using a hand held dynamometer (microFET3, Hoggan Health Industries Inc., West Jordan, UT). | Baseline, 6-months and 12-months | |
Other | Shoulder Internal Rotation Strength | Strength assessments will also be conducted by the research coordinator at baseline and 6-, and 12-months. Strength will be measured by using peak values of isometric shoulder internal rotation, using a hand held dynamometer (microFET3, Hoggan Health Industries Inc., West Jordan, UT). | Baseline, 6-months and 12-months | |
Other | Elbow supination Strength | Strength assessments will also be conducted by the research coordinator at baseline and 6-, and 12-months. Strength will be measured by using peak values of isometric elbow supination, using a hand held dynamometer (microFET3, Hoggan Health Industries Inc., West Jordan, UT). | Baseline, 6-months and 12-months | |
Other | Western Ontario Rotator Cuff Index Index (WORC) | The WORC is a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions), 21-item, disease-specific questionnaire that assesses quality of life in subjects with RC pathology. The WORC has been proven to be a valid, reliable and responsive tool in this population. | Baseline, 6-weeks, 3-months, 6-months and 12-months | |
Other | Visual analysis of biceps contraction to check for any signs of Popeye Deformity | Signs of popeye deformity will be noted during all follow-ups if any | 2-weeks, 6-weeks, 3-months, 6-months and 12-months | |
Primary | 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. | Baseline, 2-weeks, 6-weeks, 3-months, 6-months and 12-months | |
Secondary | 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. | Baseline, 6-weeks, 3-months, 6-months and 12-months |
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