Hip ArthrosisNCT02749058

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

A study testing Capsulectomy in Direct Anterior Total Hip Arthroplasty and Capsulotomy in Direct Anterior Total Hip Arthroplasty in people with Hip Arthrosis, run by IRCCS San Raffaele at 1 site in Italy.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hip Arthrosis
What is being tested?: Capsulectomy in Direct Anterior Total Hip Arthroplasty and Capsulotomy in Direct Anterior Total Hip Arthroplasty
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteItaly
Study dates: Apr 2016to Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Elective unilateral primary hip prosthesis utilizing direct anterior approach
Age ≥ 18
Signature of the informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

San Raffaele Hospital
Milan, 20132

Other trials in Italy

About this study

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.

Read the 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.

Conditions: Hip Arthrosis
Being tested: Capsulectomy in Direct Anterior Total Hip Arthroplasty, Capsulotomy in Direct Anterior Total Hip Arthroplasty
Keywords: capsulectomy, capsulotomy
Medical subject headings: Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Capsulectomy in Direct Anterior Total Hip ArthroplastyProcedure or surgery
Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
Capsulotomy in Direct Anterior Total Hip ArthroplastyProcedure or surgery
Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

Study groups in NCT02749058
Study group	Role	What they receive
Capsulectomy	Other	Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty Receives: Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty
Capsulotomy	Other	Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty Receives: Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Measured: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Measured: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)

Secondary outcomes (18)

Change in Six minutes walk test distance
Measured: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Change in Six minutes walk test distance
Measured: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Change in 30 seconds chair stand test
Measured: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Change in 30 seconds chair stand test
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 2 weeks after surgery (during inpatient stay)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Dec 2023

First posted22 Apr 2016 (estimated)
Study startApr 2016
Primary completionDec 2023 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Hip ArthrosisStudies of the same condition, open and under way.
More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 94 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02749058
Sponsor's protocol ID: CAP_Feb16
Status last verified: Feb 2023
First submitted: 14 Apr 2016
Last updated: 2 Mar 2023
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 11805930
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.
PubMed 18237703
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.
PubMed 9479711
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.
PubMed 22087603
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.
PubMed 22588756
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.
PubMed 12777182
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.
PubMed 31680746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis

All Hip Arthrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation
ClinicalTrials.gov ID: NCT02749058
Acronym / sponsor ID: CAP_Feb16
Conditions: Hip Arthrosis
Keywords: capsulectomy, capsulotomy
Study type: Interventional
Recruitment status: Suspended
Enrolment: 94 participants (estimated)
Lead sponsor: IRCCS San RaffaeleUniversity, hospital or other
Study start: Apr 2016 (actual)
Primary completion: Dec 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 22 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Capsulectomy	Other	Procedure: Capsulectomy in Direct Anterior Total Hip ArthroplastyProcedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty
Capsulotomy	Other	Procedure: Capsulotomy in Direct Anterior Total Hip ArthroplastyProcedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Elective unilateral primary hip prosthesis utilizing direct anterior approach
Age ≥ 18
Signature of the informed consent

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Capsulectomy in Direct Anterior Total Hip ArthroplastySurgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.	Procedure or surgery	Capsulectomy
Capsulotomy in Direct Anterior Total Hip ArthroplastySurgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.	Procedure or surgery	Capsulotomy

Primary outcome

Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)

18 secondary outcomes

Change in Six minutes walk test distance
Time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Change in Six minutes walk test distance
Time frame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Change in 30 seconds chair stand test
Time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Change in 30 seconds chair stand test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Active hip Range Of Motion Flexion- degree
Time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Active hip Range Of Motion Abduction- degree
Time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Active hip Range Of Motion External Rotation- degree
Time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
Active hip Range Of Motion Flexion- degree
Time frame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Active hip Range Of Motion Abduction- degree
Time frame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Active hip Range Of Motion External Rotation- degree
Time frame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Surgical time- minutes
Time frame: The day of the surgical procedure
Percent hemoglobin drop
Time frame: Up to 2 weeks after surgery (during inpatient stay)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
Background: PubMed 11805930Hewitt 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.
Background: PubMed 18237703Martin 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.
Background: PubMed 9479711Birnbaum 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.
Background: PubMed 22087603Moraes 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.
Background: PubMed 22588756Bennell 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.
Background: PubMed 12777182Nilsdotter 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.
Derived from this study: PubMed 31680746Ometti 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.
Individual participant dataSharing planned: No

Related trials for Hip Arthrosis

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marco Ometti, MD study director

IRCCS San Raffaele

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hip disability and Osteoarthritis Outcome Score (HOOS) (time frame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02749058, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.