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

NCT02749058 | Suspended DMC

• 1 other identifier: CAP_Feb16
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthrosis

Keywords

capsulectomy; capsulotomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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.

  Before surgery (T0), 50 days (plus or minus 3 days) after surgery (T1)

Study Arms (2)

Capsulectomy

OTHER

Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Capsulotomy

OTHER

Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty

Interventions

Capsulectomy in Direct Anterior Total Hip Arthroplasty PROCEDURE

Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.

Capsulectomy

Capsulotomy in Direct Anterior Total Hip Arthroplasty PROCEDURE

Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

Capsulotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

Related Publications (7)

• 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.

  PMID: 11805930 BACKGROUND

• 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.

  PMID: 18237703 BACKGROUND

• 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.

  PMID: 9479711 BACKGROUND

• 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.

  PMID: 22087603 BACKGROUND

• 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.

  PMID: 22588756 BACKGROUND

• 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.

  PMID: 12777182 BACKGROUND

• 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.

  PMID: 31680746 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Marco Ometti, MD

  IRCCS San Raffaele

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 22, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)