Immobilization in Reverse Shoulder Prosthesis

NCT ID: NCT04645329

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-04-30

Brief Summary

Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.

Conditions

Rotator Cuff Tear Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group I (no immobilization)

patients will be allowed to freely use their arm without any immobilization after surgery

Group Type: EXPERIMENTAL

shoulder immovilization sling

Intervention Type: DEVICE

immobilization of the arm after surgery

group II (3-week immobilization)

patients will be kept in an immobilization device for three weeks after surgery

Group Type: ACTIVE_COMPARATOR

shoulder immovilization sling

Intervention Type: DEVICE

immobilization of the arm after surgery

Interventions

shoulder immovilization sling

immobilization of the arm after surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy.
• age between 65-85 a.
• without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis, ...)
• acceptance to be part of the study.

Exclusion Criteria

• prosthetic surgery prior to the affected limb.
• other indications of reverse prosthesis other than rotator cuff arthropathies (acute fractures, sequelae fractures, tumor surgery, prosthetic revision surgeries).
• no acceptance to participate in the study.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar

OTHER

Sponsor Role: lead

Responsible Party

Carlos Torrens

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Torrens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief Clinic of Parc de Salut Mar

Locations

Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlos Torrens, MD, PhD

Role: CONTACT

86925@parcdesalutmar.cat

0034933674201

Facility Contacts

Carlos Torrens, MD, PhD

Role: primary

86925@parcdesalutmar.cat

0034933674201

Other Identifiers

2019/8752/I

Identifier Type: -

Identifier Source: org_study_id