Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

August 27, 2020 updated by: Thomas L Bradbury, MD, Emory University

Anterior Capsulectomy Versus Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Capsulectomy
Capsulectomy in Direct Anterior Total Hip Arthroplasty
Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty
Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
Other: Capsulotomy
Capsulotomy in Direct Anterior Total Hip Arthroplasty
Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty
Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion- Resisted Hip Flexion Strength
Time Frame: Follow Up Visit (Up to six months)

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
Time Frame: Screening Visit, Follow-up visit (Up to six months)
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
Time Frame: Screening Visit, Follow Up Visit (Up to six months)
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)
Time Frame: Screening Visit, Follow Up Visit (Up to six months)
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
Time Frame: Screening Visit, Follow Up Visit (Up to six months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hip Disability and Osteoarthritis Outcome Score
Time Frame: Screening Visit, Follow Up Visit (Up to six months)
Hip disability and osteoarthritis outcome survey (HOOS) administered to patients.
Screening Visit, Follow Up Visit (Up to six months)
Surgical Time
Time Frame: Inpatient Surgery Visit (Day 0)
This will be measured from the time of incision to the time the dressing is applied (per registered nurse (RN) operating room record).
Inpatient Surgery Visit (Day 0)
Transfusion Rate by Percent Hemoglobin Drop
Time Frame: Inpatient Surgery Visit (Day 0)
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.
Inpatient Surgery Visit (Day 0)
Number of Adverse Events
Time Frame: Duration of study (Up to six months)
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.
Duration of study (Up to six months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Thomas L Bradbury, M.D., Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00054340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis

Clinical Trials on Capsulectomy in Direct Anterior Total Hip Arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe