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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Hip Arthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Capsulectomy

Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Group Type OTHER

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Intervention Type PROCEDURE

Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.

Capsulotomy

Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

Group Type OTHER

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Intervention Type PROCEDURE

Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

Interventions

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Capsulectomy in Direct Anterior Total Hip Arthroplasty

Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.

Intervention Type PROCEDURE

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No