Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation

Study Overview
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Brief Summary
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The purpose of our study is to evaluate the differences in functional activities and proprioception after surgery in subjects who underwent hip prosthesis implant with capsulotomy or capsulectomy.

Detailed Description
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Concerning hip arthroplasty surgery, in patients affected by coxarthrosis, there are two different techniques: one is capsulectomy and the second one is capsulotomy with repairing the capsule at the end of the procedure. Both preserving and excising the capsule are accepted methods and the choice whether repairing the capsule or not is up to the surgeon, since studies have not yet demonstrated the superiority of one of the two techniques. Articular capsule has a physiological role in joint stability and proprioception. The presence of proprioceptive nerve endings in hip joint capsule has been observed both in healthy patients and in those affected by coxarthrosis. If capsulectomy is performed during primary hip arthroplasty, the pseudocapsule that is formed in place of the native capsule will not have any active neurophysiological role in the hip. For this reason, investigators compare the two surgical techniques with the purpose of highlighting, if existing, the superiority of one technique on the other in terms of better functional recovery and proprioceptive sensibility.

Official Title
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Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation

Conditions
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Hip Arthrosis

Intervention / Treatment
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* Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty
* Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective unilateral primary hip prosthesis utilizing direct anterior approach Age ≥ 18 Signature of the informed consent Exclusion Criteria: Documented peripheral neuropathies Documented central nervous system diseases that may compromise the balance and/or proprioception Presence of other joint prosthesis in the lower limbs Revision hip arthroplasty Symptomatic osteoarthritis of other joints in the lower limbs (including the controlateral hip) or the spine BMI > 35 Systemic diseases or clinical conditions that could interfere with the clinical study Neuromuscular diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Capsulectomy<br>Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty | Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty<br>* Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.<br>|
| Other: Capsulotomy<br>Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty | Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty<br>* Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hip disability and Osteoarthritis Outcome Score (HOOS) |  | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Change in Hip disability and Osteoarthritis Outcome Score (HOOS) |  | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Six minutes walk test distance |  | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Change in Six minutes walk test distance |  | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Change in 30 seconds chair stand test |  | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Change in 30 seconds chair stand test |  | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Hip Proprioception Evaluation Flexion - Measure of the absolute difference between the actual and the subject-replicated target positions. | Measures of hip flexion repositioning error (active and passive repositioning) | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions. | Measures of hip abduction repositioning error (active and passive repositioning) | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions. | Measures of hip external rotation repositioning error (active and passive repositioning) | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Hip Proprioception Evaluation Flexion- Measure of the absolute difference between the actual and the subject-replicated target positions. | Measures of hip flexion repositioning error (active and passive repositioning) | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions. | Measures of hip abduction repositioning error (active and passive repositioning) | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions. | Measures of hip external rotation repositioning error (active and passive repositioning) | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Active hip Range Of Motion Flexion- degree | Measures of hip flexion maximal active Range of Motion | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Active hip Range Of Motion Abduction- degree | Measures of hip abduction maximal active Range of Motion | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Active hip Range Of Motion External Rotation- degree | Measures of hip external rotation maximal active Range of Motion | Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1) | 
| Active hip Range Of Motion Flexion- degree | Measures of hip flexion maximal active Range of Motion | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Active hip Range Of Motion Abduction- degree | Measures of hip abduction maximal active Range of Motion | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Active hip Range Of Motion External Rotation- degree | Measures of hip external rotation maximal active Range of Motion | Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2) | 
| Surgical time- minutes | This will be measured from the time of incision to the time the dressing is applied | The day of the surgical procedure | 
| Percent hemoglobin drop | Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin. | Up to 2 weeks after surgery (during inpatient stay) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsulectomy, capsulotomy