Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

NCT02121964 | Completed

• 1 other identifier: IRB00054340
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

In this prospective, randomized study, investigators will look at the outcome of total hip arthroplasty through the anterior approach in regard to the surgical treatment of the anterior hip capsule. At this time, there are 2 different techniques: one is excising this capsule and the second one is cutting the capsule and repairing it at the end of the procedure. The investigators set out to determine whether incising or repairing the capsule will benefit the patients in terms of postoperative pain level, range of motion of the hip joint, joint stability, surgical time and blood loss. Both preserving and excising the joint capsule are accepted techniques in performing total hip arthroplasty. The Investigators hypothesize that capsulectomy may allow for reduction in operative time, provide superior surgical exposure, and increased range of motion after surgery. The influence on post operative pain and dislocation rate is unknown.

Conditions

Hip Arthrosis; Osteoarthritis; Arthritis

Keywords

unilateral primary total hip arthroplasty; bilateral primary total hip arthroplasty; Arthritis; Orthopedic Disorders; Orthopedics; Surgery,; Orthopedic; arthroplasty; hip; osteoarthritis; capsulectomy; capsulotomy

Outcome Measures

Primary Outcomes (5)

• Range of Motion- Resisted Hip Flexion Strength

  Measurement will be recorded taken with patient in the seated position with the hip flexed to 90 degrees. Strength will be measured when resistance is applied to the knee as the patient brings the leg up. The following scale will be used (each may be +/-, i.e. 5+): * 5 = NORMAL - the patient is able to actively move through the full available range of motion (ROM) against gravity and against maximal resistance * 4 = GOOD - the patient is able to actively move through the full available ROM against gravity and against moderate resistance * 3 = MODERATE - the patient is able to actively move through greater than one half the available ROM against gravity and against moderate resistance * 2 = POOR - the patient is unable to actively flex hip against gravity * 1 = BAD - the patient is unable to flex muscle properly

  Follow Up Visit (Up to six months)

• Change in Range of Motion - Maximum Hip Flexion

  This angle will be measured with the patient in the supine position utilizing a goniometer (recorded in degrees). Patients will flex the hip by bringing their leg as close to their trunk as possible with their knee bent. The angle between the trunk and leg will be recorded

  Screening Visit, Follow-up visit (Up to six months)

• Change in Range of Motion - Maximum Hip Extension

  This angle will be measured with the patient in the prone position utilizing a goniometer. The patient will raise the lower leg to the limit of extension. The angle between the leg and table is recorded.

  Screening Visit, Follow Up Visit (Up to six months)

• Change in Range of Motion - Evidence of Flexion Contraction (Thomas Test)

  This angle will be measured with the patient lying in the supine position. Patient will bring opposite knee to the chest, while the other leg remains extended. The angle between the extended leg and the table is recorded.

  Screening Visit, Follow Up Visit (Up to six months)

• Change in Pain Score with Resisted Hip Flexion

  Measured using the Pain Assessment scale (PAS) of 0-10 (0 being no pain; 10 being worst imaginable pain).

  Screening Visit, Follow Up Visit (Up to six months)

Secondary Outcomes (4)

• Change in Hip Disability and Osteoarthritis Outcome Score

  Screening Visit, Follow Up Visit (Up to six months)

• Surgical Time

  Inpatient Surgery Visit (Day 0)

• Transfusion Rate by Percent Hemoglobin Drop

  Inpatient Surgery Visit (Day 0)

• Number of Adverse Events

  Duration of study (Up to six months)

Study Arms (2)

Capsulectomy

OTHER

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty

Capsulotomy

OTHER

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 or bilateral primary total hip arthroplasty
• Direct anterior surgical approach
• Osteoarthritis diagnosis
• years of age or older

You may not qualify if:

• Revision hip arthroplasty
• Avascular necrosis of the hip
• Rheumatoid arthritis of the hip
• Younger than 18 years of age

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Related Publications (11)

• Keggi KJ, Huo MH, Zatorski LE. Anterior approach to total hip replacement: surgical technique and clinical results of our first one thousand cases using non-cemented prostheses. Yale J Biol Med. 1993 May-Jun;66(3):243-56.

  PMID: 8209560 BACKGROUND

• Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.

  PMID: 16330993 BACKGROUND

• Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.

  PMID: 21076896 BACKGROUND

• Masonis J, Thompson C, Odum S. Safe and accurate: learning the direct anterior total hip arthroplasty. Orthopedics. 2008 Dec;31(12 Suppl 2):orthosupersite.com/view.asp?rID=37187.

  PMID: 19298019 BACKGROUND

• Restrepo C, Parvizi J, Pour AE, Hozack WJ. Prospective randomized study of two surgical approaches for total hip arthroplasty. J Arthroplasty. 2010 Aug;25(5):671-9.e1. doi: 10.1016/j.arth.2010.02.002. Epub 2010 Apr 8.

  PMID: 20378307 BACKGROUND

• Bremer AK, Kalberer F, Pfirrmann CW, Dora C. Soft-tissue changes in hip abductor muscles and tendons after total hip replacement: comparison between the direct anterior and the transgluteal approaches. J Bone Joint Surg Br. 2011 Jul;93(7):886-9. doi: 10.1302/0301-620X.93B7.25058.

  PMID: 21705558 BACKGROUND

• Meneghini RM, Pagnano MW, Trousdale RT, Hozack WJ. Muscle damage during MIS total hip arthroplasty: Smith-Petersen versus posterior approach. Clin Orthop Relat Res. 2006 Dec;453:293-8. doi: 10.1097/01.blo.0000238859.46615.34.

  PMID: 17006366 BACKGROUND

• Mayr E, Nogler M, Benedetti MG, Kessler O, Reinthaler A, Krismer M, Leardini A. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech (Bristol). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21.

  PMID: 19699566 BACKGROUND

• Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023.

  PMID: 9917607 BACKGROUND

• Weeden SH, Paprosky WG, Bowling JW. The early dislocation rate in primary total hip arthroplasty following the posterior approach with posterior soft-tissue repair. J Arthroplasty. 2003 Sep;18(6):709-13. doi: 10.1016/s0883-5403(03)00254-7.

  PMID: 14513442 BACKGROUND

• Schwartz AM, Goel RK, Sweeney AP, Bradbury TL Jr. Capsular Management in Direct Anterior Total Hip Arthroplasty: A Randomized, Single-Blind, Controlled Trial. J Arthroplasty. 2021 Aug;36(8):2836-2842. doi: 10.1016/j.arth.2021.03.048. Epub 2021 Mar 26.

  PMID: 33865648 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis; Arthritis; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Joint Diseases; Rheumatic Diseases

Study Officials

• Thomas L Bradbury, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 24, 2014
• Study Start: August 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: May 31, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)