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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02786121
Other study ID # 0008317
Secondary ID
Status Completed
Phase N/A
First received April 15, 2016
Last updated August 4, 2017
Start date April 2016
Est. completion date May 2017

Study information

Verified date August 2017
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure the fear level of movement. All the other variable that could influence the ILOA Score are identified and collected: age, sex, body max index, ability of patient pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Primary hip joint replacement

- Clinical symptoms from more than 3 months

Exclusion Criteria:

- other orthopaedic surgery on the lower limb In the last year

- Not italian speaking

- Hip arthroplasty following fractures, revision surgery, and partial replacement

- Patients with concomitant neurologic (Parkinson, ictus), rheumatologic (rheumatoid arthritis) diseases,

- cognitive impaired.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Iowa Level of Assistance (ILOA) Score The outcome considered was the level of autonomy achieved by the patients at the 5th days after surgery, measured by the Iowa Level of Assistance (ILOA) scale that took into account the patient's autonomy in carrying out functional 5 activities: supine-to-sitting, sitting-to-standing, walking, climbing 3 steps, and gait speed. The total score ranged from 0 to 50, where 0 was the patient's complete autonomy and 50 the maximum dependence. The score was based on the level of help that was supplied to the patient by the operator for the safe execution of activities, with a range between 0 and 30, and the type of assistive device used with a range between 0 and 20. The physiotherapist will collect the ILOA Score. 5 days after surgery
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