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

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02749058
Enrollment
94
Registered
2016-04-22
Start date
2016-04-30
Completion date
2023-12-31
Last updated
2023-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthrosis

Keywords

capsulectomy, capsulotomy

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.

Interventions

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

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

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)

Secondary

MeasureTime frameDescription
Change in 30 seconds chair stand testBefore 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.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), 50 days (plus or minus 3 days) after surgery (T1)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), 50 days (plus or minus 3 days) after surgery (T1)Measures of hip external rotation 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), 90 days (plus or minus 3 days) after surgery (T2)Measures of hip flexion repositioning error (active and passive repositioning)
Change in Six minutes walk test distanceBefore surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Active hip Range Of Motion Abduction- degreeBefore surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)Measures of hip abduction maximal active Range of Motion
Active hip Range Of Motion External Rotation- degreeBefore surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)Measures of hip external rotation maximal active Range of Motion
Surgical time- minutesThe day of the surgical procedureThis will be measured from the time of incision to the time the dressing is applied
Percent hemoglobin dropUp 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 Flexion- degreeBefore surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)Measures of hip flexion maximal active Range of Motion

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026