Spanish health center started clinical trial of Immobilization in Reverse Shoulder Prosthesis
Photo by Jesper Aggergaard
The Hospital del Mar is conducting the clinical trial of Immobilization in Reverse Shoulder Prosthesis.
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.
Actual study start date is January 1, 2020. The researchers expect to complete the study by June 30, 2021.
Change in Pain control (visual analogical scale) is the primary outcome measure.
Study population of this clinical trial are patients patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy at the age between 65-85 years without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis).
Among the exclusion criteria are:
- 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).
The Hospital del Mar is a health center located on the Paseo Marítimo in Barcelona. It was inaugurated in 1905.
Although relatively small in size, Hospital del Mar has one of the most relevant scientific productions in the country, with the development of projects that bring science closer to the daily application in the health of the people it serves, 1 integrated into the Parc de Salut Mar.2
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04645329) Barcelona, Spain.
