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This is an observational prospective study aimed 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.
Introduction: Total hip arthroplasty (THA) represents a successful treatment for several hip joint pathologies. In case of bilateral hip joint involvement, the advancements in surgical techniques have made the development of bilateral THA surgery possible through one-stage procedure. This approach seems to be as safe as unilateral THA and safer than two-stage bilateral THA, but few studies considering functional outcomes in these patients without exploring outcomes linked to their motor and functional performance.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unilateral THA | Patients who underwent to unilateral total hip arthroplasty |
| |
| Bilateral THA | Patients who underwent to simultaneous bilateral total hip arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unilateral total hip arthroplasty | Procedure | Replacement of one hip joint through a mininvasive surgical procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight Distribution | Ability to simmetrically load their lower limbs | Before surgery, 3rd and 7th postoperative day |
| Change in Centre of Pressure Length of Trace | Ability to mantain balance | Before surgery, 3rd and 7th postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Gait analysis | Spatio-temporal parametres of the gait and joints kinematic | Before surgery and 7th postoperative day |
| Change in Numeric Rating Scale | Scale for pain assessment ranging from 0 (absence of pain) to 10 (maximum pain) |
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Inclusion Criteria:
Exclusion Criteria:
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20 patients who undergone to unilateral THA and 20 patients who undergone to simultaneous bilateral THA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roberto Gatti | Rozzano | Milan | 20089 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2017 | Dec 14, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2017 | Dec 14, 2017 | SAP_001.pdf |
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| Simultaneous bilateral total hip arthroplasty | Procedure | Replacement of both hip joints through one-stage mininvasive surgical procedure |
|
| Before surgery, 3rd and 7th postoperative day |
| Change in Timed Up and Go Test | Test for evaluating walking ability | Before surgeryand 7th postoperative day |