Immobilization in Reverse Shoulder Prosthesis

NCT04645329 | Unknown DMC

• 1 other identifier: 2019/8752/I
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain control (visual analogical scale)

  determination of pain control between groups at different time points with the aid of a visual analogical scale of 10 points, where 0 means no pain and 10 means maximum pain.

  determination of pain the day of the surgery, and then 24hours, 48hours, 7 days, 3-weeks, 3 months, 6 months, 1 year, 2 years postoperatively.

Study Arms (2)

group I (no immobilization)

EXPERIMENTAL

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

Device: shoulder immovilization sling

group II (3-week immobilization)

ACTIVE COMPARATOR

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

Device: shoulder immovilization sling

Interventions

shoulder immovilization sling DEVICE

immobilization of the arm after surgery

group I (no immobilization); group II (3-week immobilization)

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Carlos Torrens, MD, PhD

  Chief Clinic of Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Torrens, MD, PhD

CONTACT

0034933674201; 86925@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessor will be blinded to the allocation of the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Randomized prospective study. (computer-generated randomization list and saved in opaque envelopes)

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 27, 2020
• Study Start: January 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

ES (1)