Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
Primary Purpose
Hip Arthrosis
Status
Suspended
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Capsulectomy in Direct Anterior Total Hip Arthroplasty
Capsulotomy in Direct Anterior Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthrosis focused on measuring capsulectomy, capsulotomy
Eligibility Criteria
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
Sites / Locations
- San Raffaele Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Capsulectomy
Capsulotomy
Arm Description
Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty
Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty
Outcomes
Primary Outcome Measures
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Secondary Outcome Measures
Change in Six minutes walk test distance
Change in Six minutes walk test distance
Change in 30 seconds chair stand test
Change in 30 seconds chair stand test
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)
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)
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)
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)
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)
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)
Active hip Range Of Motion Flexion- degree
Measures of hip flexion maximal active Range of Motion
Active hip Range Of Motion Abduction- degree
Measures of hip abduction maximal active Range of Motion
Active hip Range Of Motion External Rotation- degree
Measures of hip external rotation maximal active Range of Motion
Active hip Range Of Motion Flexion- degree
Measures of hip flexion maximal active Range of Motion
Active hip Range Of Motion Abduction- degree
Measures of hip abduction maximal active Range of Motion
Active hip Range Of Motion External Rotation- degree
Measures of hip external rotation maximal active Range of Motion
Surgical time- minutes
This will be measured from the time of incision to the time the dressing is applied
Percent hemoglobin drop
Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02749058
Brief Title
Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
Official Title
Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthrosis
Keywords
capsulectomy, capsulotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Capsulectomy
Arm Type
Other
Arm Description
Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty
Arm Title
Capsulotomy
Arm Type
Other
Arm Description
Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Capsulectomy in Direct Anterior Total Hip Arthroplasty
Intervention Description
Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
Capsulotomy in Direct Anterior Total Hip Arthroplasty
Intervention Description
Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.
Primary Outcome Measure Information:
Title
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Secondary Outcome Measure Information:
Title
Change in Six minutes walk test distance
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Change in Six minutes walk test distance
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Change in 30 seconds chair stand test
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Change in 30 seconds chair stand test
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Hip Proprioception Evaluation Flexion - Measure of the absolute difference between the actual and the subject-replicated target positions.
Description
Measures of hip flexion repositioning error (active and passive repositioning)
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.
Description
Measures of hip abduction repositioning error (active and passive repositioning)
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.
Description
Measures of hip external rotation repositioning error (active and passive repositioning)
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Hip Proprioception Evaluation Flexion- Measure of the absolute difference between the actual and the subject-replicated target positions.
Description
Measures of hip flexion repositioning error (active and passive repositioning)
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.
Description
Measures of hip abduction repositioning error (active and passive repositioning)
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.
Description
Measures of hip external rotation repositioning error (active and passive repositioning)
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Active hip Range Of Motion Flexion- degree
Description
Measures of hip flexion maximal active Range of Motion
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Active hip Range Of Motion Abduction- degree
Description
Measures of hip abduction maximal active Range of Motion
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Active hip Range Of Motion External Rotation- degree
Description
Measures of hip external rotation maximal active Range of Motion
Time Frame
Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Title
Active hip Range Of Motion Flexion- degree
Description
Measures of hip flexion maximal active Range of Motion
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Active hip Range Of Motion Abduction- degree
Description
Measures of hip abduction maximal active Range of Motion
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Active hip Range Of Motion External Rotation- degree
Description
Measures of hip external rotation maximal active Range of Motion
Time Frame
Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Title
Surgical time- minutes
Description
This will be measured from the time of incision to the time the dressing is applied
Time Frame
The day of the surgical procedure
Title
Percent hemoglobin drop
Description
Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin.
Time Frame
Up to 2 weeks after surgery (during inpatient stay)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Ometti, MD
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Study Director
Facility Information:
Facility Name
San Raffaele Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11805930
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.
Results Reference
background
PubMed Identifier
18237703
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.
Results Reference
background
PubMed Identifier
9479711
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.
Results Reference
background
PubMed Identifier
22087603
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.
Results Reference
background
PubMed Identifier
22588756
Citation
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.
Results Reference
background
PubMed Identifier
12777182
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.
Results Reference
background
PubMed Identifier
31680746
Citation
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.
Results Reference
derived
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Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
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