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Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

Primary Purpose

Hip Arthrosis, Osteoarthritis, Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Capsulectomy in Direct Anterior Total Hip Arthroplasty
Capsulotomy in Direct Anterior Total Hip Arthroplasty
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Arthrosis focused on measuring unilateral primary total hip arthroplasty, bilateral primary total hip arthroplasty, Arthritis, Orthopedic Disorders, Orthopedics, Surgery,, Orthopedic, arthroplasty, hip, osteoarthritis, capsulectomy, capsulotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Emory University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Capsulectomy

Capsulotomy

Arm Description

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Outcomes

Primary Outcome Measures

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
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
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.
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.
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).

Secondary Outcome Measures

Change in Hip Disability and Osteoarthritis Outcome Score
Hip disability and osteoarthritis outcome survey (HOOS) administered to patients.
Surgical Time
This will be measured from the time of incision to the time the dressing is applied (per registered nurse (RN) operating room record).
Transfusion Rate by Percent Hemoglobin Drop
This will be recorded by review of inpatient medical records. Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin.
Number of Adverse Events
Patients will be assessed for complications that occur as a result of THA. These will be assessed at the standard of care intervals (6 week and 6 month follow-up visits). Any change in stem position including subsidence and radiolucencies will be reviewed.

Full Information

First Posted
April 14, 2014
Last Updated
August 27, 2020
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02121964
Brief Title
Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty
Official Title
Anterior Capsulectomy Versus Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Utilization of the direct anterior approach for total hip arthroplasty (THA) has increased over the last ten years. The approach, as described by Keggi et al, superficially utilizes the internervous muscle plane between the tensor fascia lata and the sartorius and deeply between the rectus and gluteus medius (1). Performing this muscle sparing rather than muscle splitting approach has several purported benefits. The clinical reports of this surgical approach have documented low dislocation rates (2, 3), excellent cup position (4) improved outcome scores (5), less muscle damage (6, 7) and improved gait mechanics (8). The preservation and repair of the anterior hip capsule (iliofemoral and pubofemoral ligaments) has been recommended by some authors, while anterior capsulectomy has been described by other authors without a reported increase in dislocation rate. In contrast, the higher risk of posterior dislocation using the posterior approach improved significantly after repair of the capsule (9, 10). There are no studies to date that have investigated outcome scores based on capsular repair versus capsulectomy for the THA direct anterior approach. The effects of anterior capsular repair versus capsulectomy are unknown with regards to anterior hip pain, range of motion, and surgical recovery. We 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. In this prospective, randomized clinical study investigators will compare operative time, blood loss, postoperative pain, range of motion, strength, and adverse events using two different surgical techniques (anterior capsular repair versus anterior capsulectomy) during direct anterior total hip arthroplasty. Patients will be randomized at their screening visit to one of two groups (anterior capsule repair or anterior capsulectomy), and they will be blinded for the group assignment. The surgical procedures will be performed according to the surgeon's routine standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capsulectomy
Arm Type
Other
Arm Description
Capsulectomy in Direct Anterior Total Hip Arthroplasty
Arm Title
Capsulotomy
Arm Type
Other
Arm Description
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
Range of Motion- Resisted Hip Flexion Strength
Description
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
Time Frame
Follow Up Visit (Up to six months)
Title
Change in Range of Motion - Maximum Hip Flexion
Description
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
Time Frame
Screening Visit, Follow-up visit (Up to six months)
Title
Change in Range of Motion - Maximum Hip Extension
Description
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.
Time Frame
Screening Visit, Follow Up Visit (Up to six months)
Title
Change in Range of Motion - Evidence of Flexion Contraction (Thomas Test)
Description
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.
Time Frame
Screening Visit, Follow Up Visit (Up to six months)
Title
Change in Pain Score with Resisted Hip Flexion
Description
Measured using the Pain Assessment scale (PAS) of 0-10 (0 being no pain; 10 being worst imaginable pain).
Time Frame
Screening Visit, Follow Up Visit (Up to six months)
Secondary Outcome Measure Information:
Title
Change in Hip Disability and Osteoarthritis Outcome Score
Description
Hip disability and osteoarthritis outcome survey (HOOS) administered to patients.
Time Frame
Screening Visit, Follow Up Visit (Up to six months)
Title
Surgical Time
Description
This will be measured from the time of incision to the time the dressing is applied (per registered nurse (RN) operating room record).
Time Frame
Inpatient Surgery Visit (Day 0)
Title
Transfusion Rate by Percent Hemoglobin Drop
Description
This will be recorded by review of inpatient medical records. Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin.
Time Frame
Inpatient Surgery Visit (Day 0)
Title
Number of Adverse Events
Description
Patients will be assessed for complications that occur as a result of THA. These will be assessed at the standard of care intervals (6 week and 6 month follow-up visits). Any change in stem position including subsidence and radiolucencies will be reviewed.
Time Frame
Duration of study (Up to six months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective unilateral or bilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older Exclusion Criteria: Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Bradbury, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8209560
Citation
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.
Results Reference
background
PubMed Identifier
16330993
Citation
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.
Results Reference
background
PubMed Identifier
21076896
Citation
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.
Results Reference
background
PubMed Identifier
19298019
Citation
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.
Results Reference
background
PubMed Identifier
20378307
Citation
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.
Results Reference
background
PubMed Identifier
21705558
Citation
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.
Results Reference
background
PubMed Identifier
17006366
Citation
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.
Results Reference
background
PubMed Identifier
19699566
Citation
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, Avon). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21.
Results Reference
background
PubMed Identifier
9917607
Citation
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.
Results Reference
background
PubMed Identifier
14513442
Citation
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.
Results Reference
background
PubMed Identifier
33865648
Citation
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.
Results Reference
derived

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Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

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