Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prehabilitation, Control.
- Who it may be relevant to
- Registry conditions: Rotator Cuff. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this randomized controlled trial is to investigate whether the intervention can improve the clinical outcome and patient satisfaction in elective reconstructive shoulder surgeries. The study participants are adults with a diagnosed rotator cuff tear for which surgical treatment is planned. This main question is to be answered by the study: • Does prehabilitation before elective shoulder surgeries lead to an improvement in postoperative outcomes and patient satisfaction compared to the control group? The control group receives standard information about the hospital stay, while the intervention group undergoes the prehabilitation program in the approximately 6 weeks prior to surgery. This program includes: * Information on the condition and pain management * Recommendations for behavior modification * A home exercise program Primary endpoint is the Western Ontario Rotator Cuff Index (WORC). The assessments are conducted at four time points: at study enrollment, immediately before surgery, and at 6, 12, and 24 months after surgery.
Interventions
- Procedure Prehabilitation
The waiting time until the operation is about 6 weeks. The intervention is carried out during this time: The intervention group receives a brochure with an evidence-based exercise program for the shoulder and shoulder girdle. The brochure contains pages in which the patient documents how the exercises are carried out. The exercise program is supplemented by information in the form of a video/Power Point presentation on: Anatomy/function, pain management, hospitalization and subsequent rehabilit - Procedure Control
The control group receives a leaflet with general information for the period up to the operation (e.g. buy water-resistant plasters, arrange post-op physiotherapy appointments).
Primary outcome measures
- Western Ontario Rotator Cuff Index (WORC) [Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
Secondary outcome measures (8)
- Patient survey on Treatment satisfaction and willingness to recommend [Time frame: before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- EQ-5D quality of life questionnaire [Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- Constant Murely score for self-evaluation [Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- Subjective shoulder value [Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- Survey on the use of painkillers [Time frame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- Survey on return to pre-operative sport [Time frame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- Survey on return to preoperative occupation or daily responsibilities [Time frame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
- Examination for the presence of a re-rupture [Time frame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery]
Eligibility criteria
Inclusion criteria
- Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.
Exclusion criteria
- Pre-existing fracture of the upper arm or shoulder girdle, rheumatic arthritis/fibromyalgia, additional findings in the shoulder joint (instability, frozen shoulder), neurological disease, cognitive or speech impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Kliniken der Stadt Köln gGmbH — Cologne
Identifiers
NCT: NCT06868472 · Ethics number: 150/2024