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

San Donato Group (GSD)

Status: Suspended

Conditions: Hip Arthrosis

Treatments: Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty; Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02749058

CAP_Feb16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Capsulectomy

Other group

Description:

Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Treatment:

Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Capsulotomy

Other group

Description:

Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

Treatment:

Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty