Immobilization in Reverse Shoulder Prosthesis

Sponsor

Hospital del Mar (Other)

Overall Status

Recruiting

CT.gov ID

NCT04645329

Collaborator

(none)

Enrollment

Location

Arms

51.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear Arthropathy	Device: shoulder immovilization sling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

outcomes assessor will be blinded to the allocation of the patients

Primary Purpose:

Treatment

Official Title:

Should Patients Undergoing Reverse Shoulder Prostheses Due to Arthropathy of the Rotator Cuff be Immobilized? Randomized Prospective Study

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group I (no immobilization) patients will be allowed to freely use their arm without any immobilization after surgery	Device: shoulder immovilization sling immobilization of the arm after surgery
Active Comparator: group II (3-week immobilization) patients will be kept in an immobilization device for three weeks after surgery	Device: shoulder immovilization sling immobilization of the arm after surgery

Arm

Intervention/Treatment

Experimental: group I (no immobilization)

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

Device: shoulder immovilization sling

immobilization of the arm after surgery

Active Comparator: group II (3-week immobilization)

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

Device: shoulder immovilization sling

immobilization of the arm after surgery

Outcome Measures

Primary Outcome Measures

Change in Pain control (visual analogical scale) [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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital del Mar	Barcelona		Spain	08003

Sponsors and Collaborators

Hospital del Mar

Investigators

Principal Investigator: Carlos Torrens, MD, PhD, Chief Clinic of Parc de Salut Mar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlos Torrens, MD, PhD, Hospital del Mar

ClinicalTrials.gov Identifier:

NCT04645329

Other Study ID Numbers:

2019/8752/I

First Posted:

Nov 27, 2020

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Joint Diseases

Rotator Cuff Tear Arthropathy

Rotator Cuff Injuries

Study Results

No Results Posted as of Mar 31, 2022