Short and long term comparison of a rotator cuff repair versus longhead biceps tenotomy in symptomatic elderly patients with a full thickness rotator cuff tear

Short and long term comparison of a rotator cuff repair versus longhead biceps tenotomy in symptomatic elderly patients with a full thickness rotator cuff tear - CURET

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48524

Enrollment

Registered

2019-07-18

Start date

2019-11-05

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendon tear

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient is >65 years old; - Complete rotator cuff tear; - Signed informed consent; - Conservative treatment failure (of at least 6 months).

Exclusion criteria

Exclusion criteria: - previous shoulder operation, glenohumeral osteoarthritis and osteoarthritis of the acromioclavicular joint, additional schoulder operation; - Subjects with any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the study; - Inability to communicate pain perception; - Neuromuscular injury or disorder.

Design outcomes

Primary

Measure	Time frame
Primary outcome will be the difference between the pre-operative and postoperative Disabilities of the Arm, Shoulder and Hand (DASH) score in patients treated with a LHB tenotomy and a rotator cuff repair. This is 30-item previously validated questionnaire that the patient fills in, designed to evaluate physical function and symptoms in people with any musculoskeletal disorder of the upper limb .	—

Secondary

Measure	Time frame
Secondary outcomes includes an evaluation of the repaired rotator cuff, patient-perceived pain and functional improvement, visual analogue scale (VAS) pain scores, anchor questions on pain and satisfaction, and the EuroQol-5D (EQ-5D). An intact cuff will be determined based on echographic imaging performed by an expert operator. This will be evautated on location, tear thickness and Pain intensity will be measured on a VAS scale of 0 to 10 where 0 represents no pain and 10 represents unbearable pain. Patients will be asked to point this out on a visual scale, one score representing pain at rest and one score representing pain during activity will be obtained. Patient satisfaction was scored as very satisfied, satisfied, somewhat satisfied, disappointed, or unhappy with the result of surgery. Patient-perceived pain and functional improvement will be measured with two anchor questions in which patients were asked to indicate on a global rating scale how much their pain (pain anchor) or function (functional anchor) had changed after surgery The response options for the anchor questions were: completely recovered, much improved, slightly improved, unchanged, slightly worse, much worse, and worse than ever.The EQ-5D is a patient-perceived quality-of-life questionnaire with five questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Other study parameter(s) Other demographic and clinical parameters that will be used to measure surgery outcomes include: tear length, age, gender, hand-dominance, duration of shoulder complaints prior operation and adverse events.	—

Measure

Time frame

Secondary outcomes includes an evaluation of the repaired rotator cuff, patient-perceived pain and functional improvement, visual analogue scale (VAS) pain scores, anchor questions on pain and satisfaction, and the EuroQol-5D (EQ-5D). An intact cuff will be determined based on echographic imaging performed by an expert operator. This will be evautated on location, tear thickness and Pain intensity will be measured on a VAS scale of 0 to 10 where 0 represents no pain and 10 represents unbearable pain. Patients will be asked to point this out on a visual scale, one score representing pain at rest and one score representing pain during activity will be obtained. Patient satisfaction was scored as very satisfied, satisfied, somewhat satisfied, disappointed, or unhappy with the result of surgery. Patient-perceived pain and functional improvement will be measured with two anchor questions in which patients were asked to indicate on a global rating scale how much their pain (pain anchor) or function (functional anchor) had changed after surgery The response options for the anchor questions were: completely recovered, much improved, slightly improved, unchanged, slightly worse, much worse, and worse than ever.The EQ-5D is a patient-perceived quality-of-life questionnaire with five questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Other study parameter(s) Other demographic and clinical parameters that will be used to measure surgery outcomes include: tear length, age, gender, hand-dominance, duration of shoulder complaints prior operation and adverse events.

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Countries

Netherlands

Outcome results