Biceps Tendon Lesion Clinical Trial
— TenTedOfficial title:
TenTed-Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair
| Verified date | December 2022 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The most important functions of the biceps brachii muscle are flexion and supination of the elbow. Patients with a partial or complete rotator cuff tear often suffer a lesion of the long head of the biceps tendon (LHBT). The two most common surgical treatments options are tenotomy or tenodesis. This study is to assess the Supination Strength Index (SSI) (the operated side in relation to the healthy side) after proximal biceps tenotomy versus tenodesis.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | March 5, 2020 |
| Est. primary completion date | March 5, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis - 1-4 years postoperative - Written informed consent Exclusion Criteria: - Inability to provide informed consent - Previous biceps injury and or operation - Contralateral biceps injury - Neurological disorders potentially affecting upper extremity muscle strength. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Orthopädie/Traumatologie University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Supination Strength Index SSI | comparison of the Supination Strength Index SSI (the operated side in relation to the healthy side). It is calculated by dividing the strength on the operated side by the strength on the healthy side. | at Baseline | |
| Secondary | patient's pain visual analog scale Score (VAS) | patient's pain visual analog scale score (VAS): 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable | at Baseline | |
| Secondary | American Shoulder and Elbow Surgeons (ASES) Score | The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Calculation of the ASES score is a complicated process. The final pain score is calculated via an independent formula, while the raw score from the functional questions is multiplied by a coefficient to get the final score for the functional questions. The pain and functional portions are then summed to obtain the final ASES score with higher scores indicating better outcomes | at Baseline | |
| Secondary | Constant Score | This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately.
The subjective variables are pain and activities of daily living (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 points. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. |
at Baseline | |
| Secondary | Long head of Biceps Score (LHB-Score) | The LHB score (maximum 100 points) described by Scheibel et al. evaluates the qualities ''biceps pain and muscle cramps'' (maximum 50 points), ''cosmesis" (maximum 30 points) and ''flexion strength at the elbow'' (maximum 20 points) | at Baseline | |
| Secondary | muscle activation determined from electromyographic (EMG) data | The level of muscle activation of the biceps during forearm supination will be expressed as percentage of the peak muscle activation during elbow flexion and compared between the limbs of each patient. The mean frequency of the muscle activation will be calculated using a Fast Fourier Transform in 1s windows. Fatigue will be determined as the change in the mean frequency from the beginning of the endurance task to the end of the endurance task | at Baseline | |
| Secondary | supination muscle strength | Isometric endurance of forearm supination will be measured in neutral forearm. Participants will be asked to maximally supinate their forearm for as long as possible. Endurance will be quantified as the elapsed time until the patient stops the measurement due to fatigue. | at Baseline |