Clinical trial NCT04393662: Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair
Official title: TenTed-Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biceps Tendon Lesion
Keywords: partial rotator cuff tear
complete rotator cuff tear
proximal biceps tenotomy
proximal biceps tenodesis
arthroscopic rotator cuff tear repair
biceps strength in supination and flexion
Supination Strength Index SSI
lesion of the long head of the biceps tendon (LHBT)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be asked to participate in clinical and functional analysis after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis (1 to 4 years after surgery) at the University Hospital Basel between Jan 2015 and Oct 2018.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Supination Strength Index SSI
timeFrame: at Baseline
Secondary outcomes:
measure: patient's pain visual analog scale Score (VAS)
timeFrame: at Baseline
measure: American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: at Baseline
measure: Constant Score
timeFrame: at Baseline
measure: Long head of Biceps Score (LHB-Score)
timeFrame: at Baseline
measure: muscle activation determined from electromyographic (EMG) data
timeFrame: at Baseline
measure: supination muscle strength
timeFrame: at Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Orthopädie/Traumatologie University Hospital Basel
Study officials:
affiliation: Orthopädie/Traumatologie University Hospital Basel
name: Andreas Mueller, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: