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

P

Prof. Arasch Wafaisade

Status

Not yet enrolling

Conditions

Rotator Cuff

Treatments

Procedure: Control
Procedure: Prehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06868472
Ethics number: 150/2024

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 2 patient groups, including a placebo group

Prehabilitation-Group
Active Comparator group
Treatment:
Procedure: Prehabilitation
Control-Group
Placebo Comparator group
Treatment:
Procedure: Control

Trial contacts and locations

1

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Central trial contact

Arasch Wafaisade, Prof. Dr. med.; Ute Westphal

Data sourced from clinicaltrials.gov

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