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

Not Applicable

Suspended

• Conditions: Hip Arthrosis
• Interventions: Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty; Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

• Registration Number: NCT02749058
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsulotomy	Capsulotomy in Direct Anterior Total Hip Arthroplasty	Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty
Capsulectomy	Capsulectomy in Direct Anterior Total Hip Arthroplasty	Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy