Clinical trial NCT02749058: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Hip Arthrosis
Keywords: capsulectomy
capsulotomy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
Secondary outcomes:
measure: Change in Six minutes walk test distance
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Change in Six minutes walk test distance
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Change in 30 seconds chair stand test
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Change in 30 seconds chair stand test
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Hip Proprioception Evaluation Flexion - Measure of the absolute difference between the actual and the subject-replicated target positions.
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Hip Proprioception Evaluation Flexion- Measure of the absolute difference between the actual and the subject-replicated target positions.
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Hip Proprioception Evaluation Abduction - Measure of the absolute difference between the actual and the subject-replicated target positions.
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Hip Proprioception Evaluation External Rotation- Measure of the absolute difference between the actual and the subject-replicated target positions.
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Active hip Range Of Motion Flexion- degree
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Active hip Range Of Motion Abduction- degree
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Active hip Range Of Motion External Rotation- degree
timeFrame: Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)
measure: Active hip Range Of Motion Flexion- degree
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Active hip Range Of Motion Abduction- degree
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Active hip Range Of Motion External Rotation- degree
timeFrame: Before surgery (T0), 90 days (plus or minus 3 days) after surgery (T2)
measure: Surgical time- minutes
timeFrame: The day of the surgical procedure
measure: Percent hemoglobin drop
timeFrame: Up to 2 weeks after surgery (during inpatient stay)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
Study officials:
affiliation: IRCCS San Raffaele
name: Marco Ometti, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.