Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery

NCT ID: NCT06868472

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2029-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prehabilitation-Group

Group Type ACTIVE_COMPARATOR

Prehabilitation

Intervention Type PROCEDURE

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 rehabilitation.

After 2 and after 4 weeks, the physiotherapist who has explained the exercise program will contact you by telephone/zoom.

Control-Group

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

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).

Interventions

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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 rehabilitation.

After 2 and after 4 weeks, the physiotherapist who has explained the exercise program will contact you by telephone/zoom.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Arasch Wafaisade

OTHER

Sponsor Role lead

Responsible Party

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Prof. Arasch Wafaisade

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kliniken der Stadt Köln gGmbH

Cologne, , Germany

Site Status

Countries

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Germany

Central Contacts

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Arasch Wafaisade, Prof. Dr. med.

Role: CONTACT

+49-221-8907-18600

Ute Westphal

Role: CONTACT

+49-221-8907-2421

Facility Contacts

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Arasch Wafaisade, Prof. Dr. med.

Role: primary

+49221 890718600

Ute Westphal

Role: backup

+49221 89072429

Other Identifiers

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Ethics number: 150/2024

Identifier Type: -

Identifier Source: org_study_id

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