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

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.

Study Overview

• Status: Suspended
• Conditions: Hip Arthrosis
• Intervention / Treatment: Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty; Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

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 Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Capsulectomy; Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty	Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty; Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
Other: Capsulotomy; Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Study Director: Marco Ometti, MD, IRCCS San Raffaele

Publications and helpful links

General Publications

• Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
• Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.
• Nilsdotter AK, Lohmander LS, Klassbo M, Roos EM. Hip disability and osteoarthritis outcome score (HOOS)--validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003 May 30;4:10. doi: 10.1186/1471-2474-4-10. Epub 2003 May 30.
• Hewitt JD, Glisson RR, Guilak F, Vail TP. The mechanical properties of the human hip capsule ligaments. J Arthroplasty. 2002 Jan;17(1):82-9. doi: 10.1054/arth.2002.27674.
• Martin HD, Savage A, Braly BA, Palmer IJ, Beall DP, Kelly B. The function of the hip capsular ligaments: a quantitative report. Arthroscopy. 2008 Feb;24(2):188-95. doi: 10.1016/j.arthro.2007.08.024. Epub 2007 Nov 26.
• Moraes MR, Cavalcante ML, Leite JA, Macedo JN, Sampaio ML, Jamacaru VF, Santana MG. The characteristics of the mechanoreceptors of the hip with arthrosis. J Orthop Surg Res. 2011 Nov 16;6:58. doi: 10.1186/1749-799X-6-58.
• Ometti M, Brambilla L, Gatti R, Tettamanti A, La Cava T, Pironti P, Fraschini G, Salini V. Capsulectomy vs capsulotomy in total hip arthroplasty. Clinical outcomes and proprioception evaluation: Study protocol for a randomized, controlled, double blinded trial. J Orthop. 2019 Sep 12;16(6):526-533. doi: 10.1016/j.jor.2019.09.020. eCollection 2019 Nov-Dec.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: capsulotomy; capsulectomy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: CAP_Feb16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO