Hip ArthrosisNCT02121964
Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty
A study testing Capsulectomy in Direct Anterior Total Hip Arthroplasty and Capsulotomy in Direct Anterior Total Hip Arthroplasty in people with Hip Arthrosis and Osteoarthritis, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthrosis, Osteoarthritis, Arthritis
- What is being tested?
- Capsulectomy in Direct Anterior Total Hip Arthroplasty and Capsulotomy in Direct Anterior Total Hip Arthroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective unilateral or bilateral primary total hip arthroplasty
- Direct anterior surgical approach
- Osteoarthritis diagnosis
- 18 years of age or older
Who cannot join
- Revision hip arthroplasty
- Avascular necrosis of the hip
- Rheumatoid arthritis of the hip
- Younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Arthrosis, Osteoarthritis, Arthritis
- Being tested
- Capsulectomy in Direct Anterior Total Hip Arthroplasty, Capsulotomy in Direct Anterior Total Hip Arthroplasty
- Keywords
- unilateral primary total hip arthroplasty, bilateral primary total hip arthroplasty, Arthritis, Orthopedic Disorders, Orthopedics, Surgery,, Orthopedic, arthroplasty, hip, osteoarthritis, capsulectomy, capsulotomy
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Arthritis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsulectomy in Direct Anterior Total Hip ArthroplastyProcedure or surgery
Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
Capsulotomy in Direct Anterior Total Hip ArthroplastyProcedure or surgery
Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.
| Study group | Role | What they receive |
|---|---|---|
| Capsulectomy | Other | Capsulectomy in Direct Anterior Total Hip Arthroplasty Receives: Procedure: Capsulectomy in Direct Anterior Total Hip Arthroplasty |
| Capsulotomy | Other | Capsulotomy in Direct Anterior Total Hip Arthroplasty Receives: Procedure: Capsulotomy in Direct Anterior Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Screening Visit, Follow Up Visit (Up to six months)
Secondary outcomes (4)
Change in Hip Disability and Osteoarthritis Outcome Score
Hip disability and osteoarthritis outcome survey (HOOS) administered to patients.
Measured: Screening Visit, Follow Up Visit (Up to six months)
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).
Measured: Inpatient Surgery Visit (Day 0)
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.
Measured: Inpatient Surgery Visit (Day 0)
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.
Measured: Duration of study (Up to six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startAug 2013
- Primary completion31 Dec 2016
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hip ArthrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas L Bradbury, MD, Emory University
- Investigators
- Thomas L Bradbury, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121964
- Sponsor's protocol ID
- IRB00054340
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2014
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 8209560Matta 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.
PubMed 16330993Restrepo 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.
PubMed 21076896Masonis 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.
PubMed 19298019Restrepo 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.
PubMed 20378307Bremer 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.
PubMed 21705558Meneghini 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.
PubMed 17006366Mayr 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.
PubMed 19699566Pellicci 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.
PubMed 9917607Weeden 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.
PubMed 14513442Schwartz 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.
PubMed 33865648
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Capsulectomy Versus Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02121964
- Acronym / sponsor ID
- IRB00054340
- Conditions
- Hip Arthrosis, Osteoarthritis, Arthritis
- Keywords
- unilateral primary total hip arthroplasty, bilateral primary total hip arthroplasty, Arthritis, Orthopedic Disorders, Orthopedics, Surgery,, Orthopedic, arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsulectomy | Other | Procedure: Capsulectomy in Direct Anterior Total Hip ArthroplastyCapsulectomy in Direct Anterior Total Hip Arthroplasty |
| Capsulotomy | Other | Procedure: Capsulotomy in Direct Anterior Total Hip ArthroplastyCapsulotomy in Direct Anterior Total Hip Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective unilateral or bilateral primary total hip arthroplasty
- Direct anterior surgical approach
- Osteoarthritis diagnosis
- 18 years of age or older
Key exclusion criteria (4 listed)
- Revision hip arthroplasty
- Avascular necrosis of the hip
- Rheumatoid arthritis of the hip
- Younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsulectomy in Direct Anterior Total Hip ArthroplastySurgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty. | Procedure or surgery | Capsulectomy |
| Capsulotomy in Direct Anterior Total Hip ArthroplastySurgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule. | Procedure or surgery | Capsulotomy |
Primary outcome
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
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
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.
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.
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).
4 secondary outcomes
Change in Hip Disability and Osteoarthritis Outcome Score
Time frame: Screening Visit, Follow Up Visit (Up to six months)
Surgical Time
Time frame: Inpatient Surgery Visit (Day 0)
Transfusion Rate by Percent Hemoglobin Drop
Time frame: Inpatient Surgery Visit (Day 0)
Number of Adverse Events
Time frame: Duration of study (Up to six months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Background: PubMed 8209560Keggi 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.
- Background: PubMed 16330993Matta 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.
- Background: PubMed 21076896Restrepo 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.
- Background: PubMed 19298019Masonis 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.
- Background: PubMed 20378307Restrepo 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.
- Background: PubMed 21705558Bremer 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.
- Background: PubMed 17006366Meneghini 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.
- Background: PubMed 19699566Mayr 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.
- Background: PubMed 9917607Pellicci 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.
- Background: PubMed 14513442Weeden 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.
- Derived from this study: PubMed 33865648Schwartz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas L Bradbury, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsulectomy in Direct Anterior Total Hip Arthroplasty and Capsulotomy in Direct Anterior Total Hip Arthroplasty in people with Hip Arthrosis and Osteoarthritis, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion- Resisted Hip Flexion Strength (time frame: Follow Up Visit (Up to six months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121964, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.