Postoperative Biceps Strength and Electromyographic Activity After Proximal Biceps Tenotomy Versus Tenodesis in Patients With Arthroscopic Rotator Cuff Tear Repair

NCT04393662 | Completed

• 1 other identifier: 2019-02004; ch20Taha
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• patient's pain visual analog scale Score (VAS)

  at Baseline

• American Shoulder and Elbow Surgeons (ASES) Score

  at Baseline

• Constant Score

  at Baseline

• Long head of Biceps Score (LHB-Score)

  at Baseline

• muscle activation determined from electromyographic (EMG) data

  at Baseline

Study Arms (2)

Tenodesis group

Tenodesis as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT)

Diagnostic Test: Measurement of Muscle strength using a dynamometer; Diagnostic Test: Range of motion clinical measurement (shoulder and elbow); Diagnostic Test: Electromyography (EMG)

Tenotomy group

Tenotomy as surgical treatment option for a lesion of the long head of the biceps tendon (LHBT)

Diagnostic Test: Measurement of Muscle strength using a dynamometer; Diagnostic Test: Range of motion clinical measurement (shoulder and elbow); Diagnostic Test: Electromyography (EMG)

Interventions

Measurement of Muscle strength using a dynamometer DIAGNOSTIC_TEST

Muscle strength will be measured in the elbow bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). Supination tests will be performed with the forearm in neutral position, 60° pronation and 60° supination. The elbow will be in 90° flexion, and the shoulder in 45° flexion. Constant pressure is applied to lever of device for 3 to 5 seconds. Maximum torque will be recorded automatically. For each position, three repetitions of 3s (to 5s) contractions will be performed with a break of 15 (or 30s) between the repetitions. There will be an additional break of 2 minutes between measurements of the supination strength in the different positions. This parameter will be analysed regarding asymmetry between both limbs. Isometric endurance of forearm supination will be measured in neutral forearm. Flexion tests will be carried in the same setting as for supination. Flexion tests will be performed with the elbow in 90, 45 and 0° of flexion.

Tenodesis group; Tenotomy group

Range of motion clinical measurement (shoulder and elbow) DIAGNOSTIC_TEST

The range of motion parameters (degree) of both shoulders and elbows will be documented. The circumference of the arm will be measured on the line between the medial acromion and the cubital fossa at 1/3 from the cubital fossa

Tenodesis group; Tenotomy group

Electromyography (EMG) DIAGNOSTIC_TEST

Electromyographic (EMG) data will be collected using a wireless EMG system (myon AG, Schwarzenberg, Switzerland). Surface electrodes will be placed bilaterally on biceps and triceps following the guidelines of the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles)

Tenodesis group; Tenotomy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient after an arthroscopic rotator cuff repair who underwent a biceps tenotomy or tenodesis
• years postoperative
• Written informed consent

You may not qualify if:

• Inability to provide informed consent
• Previous biceps injury and or operation
• Contralateral biceps injury
• Neurological disorders potentially affecting upper extremity muscle strength.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Orthopädie/Traumatologie University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Electromyography

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Andreas Mueller, PD Dr. med.

  Orthopädie/Traumatologie University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: November 25, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

CH (1)