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

Hip Arthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02749058
• Other study ID #: CAP_Feb16
• Status: Suspended
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 94
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthrosis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Procedure:
• Capsulectomy in Direct Anterior Total Hip Arthroplasty
Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
• 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.

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hip disability and Osteoarthritis Outcome Score (HOOS)		Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Primary	Change in Hip disability and Osteoarthritis Outcome Score (HOOS)		Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Secondary	Change in Six minutes walk test distance		Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Secondary	Change in Six minutes walk test distance		Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Secondary	Change in 30 seconds chair stand test		Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Secondary	Change in 30 seconds chair stand test		Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)