Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
40 participants
OBSERVATIONAL
2018-01-01
2018-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Functional Rehabilitation in Patients Undergoing Physiotherapy After Total Hip Arthroplasty
NCT01491048
Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
NCT02749058
Retrospective Evaluation of Clinical and Functional Results and Survivorship of Total Knee Replacement and Total Hip Replacement, Both Isolated or Combined.
NCT04199377
Total Hip Arthroplasty: Fast Track Protocol is the Future?
NCT03875976
Fast-track Rehabilitation After Total Knee or Hip Arthroplasty
NCT03035435
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objective: the aim of the study is to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.
Methods: 20 patients underwent to unilateral THA and 20 patients underwent to simultaneous bilateral THA will be recruited in the study. The partecipants will be aged from 40 to 65 years old, they will be undergone to primary THA for arthritis and the will be able to walk for 50 m without aids. Patients with severe dysplasia (Crowe III and IV), anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint, with traumatic event, or previous femoral and / or pelvic osteotomy, will be excluded from the study. Weight distribution and postural stability will be evaluated asking to participants to stay on two stabilometric platform with open eyes and closed eyes for 45 seconds. Gait analysis will be used to evaluate the spatio-temporal gait parametres and the ankle, knee, hip and pelvic kinematic. Pain during walking and patients' walking ability will be also evaluated throught Numeric Rating Scale (NRS) and Timed Up and Go test (TUG). Outcome measures will be collected the day before surgery, after three, seven and about forty days after surgery, except for gait analysis and Time Up and Go tests, which will not be recorded after three days.
Statistical analysis: normality and homogeneity of demographic variables and outcome measures at the baseline will be verified. Intergroup and intra-group post-intervention differences related to outcome measures will be investigated through ANOVA for repeated measurements including post hoc analysis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Unilateral THA
Patients who underwent to unilateral total hip arthroplasty
Unilateral total hip arthroplasty
Replacement of one hip joint through a mininvasive surgical procedure
Bilateral THA
Patients who underwent to simultaneous bilateral total hip arthroplasty
Simultaneous bilateral total hip arthroplasty
Replacement of both hip joints through one-stage mininvasive surgical procedure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Unilateral total hip arthroplasty
Replacement of one hip joint through a mininvasive surgical procedure
Simultaneous bilateral total hip arthroplasty
Replacement of both hip joints through one-stage mininvasive surgical procedure
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* primary THA for osteoarthritis
* ability to walk for 50 m without aids
Exclusion Criteria
* anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
* traumatic event
* previous femoral and / or pelvic osteotomy
40 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Clinico Humanitas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Roberto Gatti
Rozzano, Milan, Italy
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLF17/02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.