Clinical trial NCT06868472: Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
Official title: Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff
Keywords: Preoperative Exercise
Enhanced Recovery After Surgery
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Secondary outcomes:
measure: Patient survey on Treatment satisfaction and willingness to recommend
timeFrame: before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: EQ-5D quality of life questionnaire
timeFrame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: Constant Murely score for self-evaluation
timeFrame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: Subjective shoulder value
timeFrame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: Survey on the use of painkillers
timeFrame: Inclusion in the study (T0), before surgery (T1); 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: Survey on return to pre-operative sport
timeFrame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: Survey on return to preoperative occupation or daily responsibilities
timeFrame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
measure: Examination for the presence of a re-rupture
timeFrame: 6 months (T2), 12 months (T3) and 24 months (T4) after surgery
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Kliniken der Stadt Köln gGmbH
Study officials:
References: