Femoro Acetabular ImpingementPhase 4NCT06500364
Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study
A Phase 4 study testing LoopLoc Arm in people with Femoro Acetabular Impingement, run by American Hip Institute at 1 site in United States.
Trial summary
The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available. The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- LoopLoc Arm
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2024to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing a primary hip arthroscopy
- Patients younger than 60 years old.
- Patients who will receive capsular closure with the Arthrex LoopLocTM device following hip arthroscopy.
Who cannot join
- Patients that had previous hip surgery,
- Patients that had a center edge angle (CEA) less than 25 degrees or greater than 40 degrees.
- Patients that have a cartilage damage grade greater than or equal to 3.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
American Hip Institute Research Foundation
Des Plaines, Illinois, 60018
Alexandra Mantice, 8472829808, foundation@americanhipinstitute.org
About this study
The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available.
The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. During hip arthroscopy, this tissue must be cut through in order to perform the hip arthroscopy. Once the hip arthroscopy is completed, the surgeon might repair the capsule. Current ways of repairing the capsule include knotted suture that might irritate structures around the hip, leading to the possible formation of scar tissue and pain. The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes.
Therefore, researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used, to see if there is a difference in their outcomes following surgery.
Read the detailed description
The purpose of the study is to perform a prospective multi-center study evaluating the feasibility of a knotless capsular closure device in patients undergoing primary hip arthroscopy.
All patients that meet study inclusion and exclusion criteria will then be informed about the study and given the IRB-approved consent form. All patients will learn about the study during a clinic visit and will have the opportunity to review the consent form and ask questions. All questions and concerns about study participation and the consent form will be addressed by staff and staff will ensure patient understanding of the consent form. The study participant will then sign and date the consent form, as well as the research staff obtaining consent. Consent can be withdrawn at any time the participant chooses either verbally or in writing.
Patients will be indicated by their physician for a capsular closuring using the LoopLocTM device. These patients will follow up for two years with their providers and researchers, who will collect their patient-reported and clinical outcomes. Data from this study will be analyzed to determine if the LoopLocTM device for capsular closure has better outcomes than the alternative treatments available.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- LoopLoc Arm, Control Arm
- Keywords
- Hip arthroscopy, Hip capsule
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoopLoc ArmDevice
Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
Control ArmDevice
Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.
| Study group | Role | What they receive |
|---|---|---|
| LoopLoc Arm | Experimental | The patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule. Receives: Device: LoopLoc Arm |
| Control Arm | Active comparator | This is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device. Receives: Device: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Harris Hip Score
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Measured: 2 years
Secondary outcomes (5)
Non-Arthritic Hip Score
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Measured: 2 years
International Hip Outcome Tool
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Measured: 2 years
Hip Outcome Score Sports-Specific Subscale
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Measured: 2 years
Visual Analog Scale
Patient-reported outcome measure. Scale 0-10, 10 indicating most amount of pain possible.
Measured: 2 years
Patient Satisfaction
Patient-reported outcome measure. Scale 0-10, 10 indicating the highest level of satisfaction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start29 Oct 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2027 (estimated)
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 Femoro Acetabular ImpingementStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Hip Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500364
- Sponsor's protocol ID
- IIRR-01891
- Status last verified
- Dec 2024
- First submitted
- 9 Jul 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barber FA, Lee Evanson JR. Editorial Commentary: Acetabular Labral Repair-Is A Knotless Anchor Better? Arthroscopy. 2019 Jan;35(1):77-79. doi: 10.1016/j.arthro.2018.09.003.
PubMed 30611369Carbone AD, Prabhavalkar O, Chishti Z, Curley AJ, Parsa A, Domb BG. Hip Capsular Repair Results in Improved Patient-Reported Outcomes and Survivorship: A Systematic Review of the Literature. Arthroscopy. 2023 Feb;39(2):488-497. doi: 10.1016/j.arthro.2022.11.013. Epub 2022 Nov 14.
PubMed 36395962Conaway WK, Martin SD. Puncture Capsulotomy During Hip Arthroscopy for Femoroacetabular Impingement: Preserving Anatomy and Biomechanics. Arthrosc Tech. 2017 Nov 27;6(6):e2265-e2269. doi: 10.1016/j.eats.2017.08.036. eCollection 2017 Dec.
PubMed 29349029Beck EC, Cvetanovich GL, Levy DM, Weber AE, Kuhns BD, Khair MM, Rasio J, Nho SJ. A T-capsulotomy provides increased hip joint visualization compared with an extended interportal capsulotomy: commentary response. J Hip Preserv Surg. 2019 Nov 23;6(3):290-291. doi: 10.1093/jhps/hnz043. eCollection 2019 Aug. No abstract available.
PubMed 31798933Domb BG, Chaharbakhshi EO, Perets I, Walsh JP, Yuen LC, Ashberg LJ. Patient-Reported Outcomes of Capsular Repair Versus Capsulotomy in Patients Undergoing Hip Arthroscopy: Minimum 5-Year Follow-up-A Matched Comparison Study. Arthroscopy. 2018 Mar;34(3):853-863.e1. doi: 10.1016/j.arthro.2017.10.019. Epub 2018 Jan 17.
PubMed 29373289Economopoulos KJ, Chhabra A, Kweon C. Prospective Randomized Comparison of Capsular Management Techniques During Hip Arthroscopy. Am J Sports Med. 2020 Feb;48(2):395-402. doi: 10.1177/0363546519894301. Epub 2019 Dec 31.
PubMed 31891553Looney AM, McCann JA, Connolly PT, Comfort SM, Curley AJ, Postma WF. Routine Capsular Closure With Hip Arthroscopic Surgery Results in Superior Outcomes: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Jun;50(7):2007-2022. doi: 10.1177/03635465211023508. Epub 2021 Aug 17.
PubMed 34403279Monroe EJ, Chambers CC, Zhang AL. Periportal Capsulotomy: A Technique for Limited Violation of the Hip Capsule During Arthroscopy for Femoroacetabular Impingement. Arthrosc Tech. 2019 Jan 28;8(2):e205-e208. doi: 10.1016/j.eats.2018.10.015. eCollection 2019 Feb.
PubMed 30906690Ortiz-Declet V, Mu B, Chen AW, Litrenta J, Perets I, Yuen LC, Domb BG. Should the Capsule Be Repaired or Plicated After Hip Arthroscopy for Labral Tears Associated With Femoroacetabular Impingement or Instability? A Systematic Review. Arthroscopy. 2018 Jan;34(1):303-318. doi: 10.1016/j.arthro.2017.06.030. Epub 2017 Aug 31.
PubMed 28866345Radha S, Hutt J, Lall A, Domb B, Lynch TS, Griffin D, Field RE, Chuck-Cakic J. Best practice guidelines for arthroscopic intervention in femoroacetabular impingement syndrome: results from an International Delphi Consensus Project-Phase 1. J Hip Preserv Surg. 2019 Dec 16;6(4):326-338. doi: 10.1093/jhps/hnz055. eCollection 2019 Dec.
PubMed 32015889Willimon SC, Briggs KK, Philippon MJ. Intra-articular adhesions following hip arthroscopy: a risk factor analysis. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):822-5. doi: 10.1007/s00167-013-2728-0. Epub 2013 Oct 26.
PubMed 24162717
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study
- ClinicalTrials.gov ID
- NCT06500364
- Acronym / sponsor ID
- IIRR-01891
- Conditions
- Femoro Acetabular Impingement
- Keywords
- Hip arthroscopy, Hip capsule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American Hip InstituteUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- 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.
The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available.
The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. During hip arthroscopy, this tissue must be cut through in order to perform the hip arthroscopy. Once the hip arthroscopy is completed, the surgeon might repair the capsule. Current ways of repairing the capsule include knotted suture that might irritate structures around the hip, leading to the possible formation of scar tissue and pain. The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes.
Therefore, researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used, to see if there is a difference in their outcomes following surgery.
Detailed description
The purpose of the study is to perform a prospective multi-center study evaluating the feasibility of a knotless capsular closure device in patients undergoing primary hip arthroscopy.
All patients that meet study inclusion and exclusion criteria will then be informed about the study and given the IRB-approved consent form. All patients will learn about the study during a clinic visit and will have the opportunity to review the consent form and ask questions. All questions and concerns about study participation and the consent form will be addressed by staff and staff will ensure patient understanding of the consent form. The study participant will then sign and date the consent form, as well as the research staff obtaining consent. Consent can be withdrawn at any time the participant chooses either verbally or in writing.
Patients will be indicated by their physician for a capsular closuring using the LoopLocTM device. These patients will follow up for two years with their providers and researchers, who will collect their patient-reported and clinical outcomes. Data from this study will be analyzed to determine if the LoopLocTM device for capsular closure has better outcomes than the alternative treatments available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LoopLoc Arm | Experimental | Device: LoopLoc ArmThe patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule. |
| Control Arm | Active comparator | Device: Control ArmThis is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing a primary hip arthroscopy
- Patients younger than 60 years old.
- Patients who will receive capsular closure with the Arthrex LoopLocTM device following hip arthroscopy.
Key exclusion criteria (3 listed)
- Patients that had previous hip surgery,
- Patients that had a center edge angle (CEA) less than 25 degrees or greater than 40 degrees.
- Patients that have a cartilage damage grade greater than or equal to 3.
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 |
|---|---|---|
| LoopLoc ArmPatients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy. | Device | LoopLoc Arm |
| Control ArmPatients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy. | Device | Control Arm |
Primary outcome
Modified Harris Hip Score
Time frame: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
5 secondary outcomes
Non-Arthritic Hip Score
Time frame: 2 years
International Hip Outcome Tool
Time frame: 2 years
Hip Outcome Score Sports-Specific Subscale
Time frame: 2 years
Visual Analog Scale
Time frame: 2 years
Patient Satisfaction
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Background: PubMed 30611369Barber FA, Lee Evanson JR. Editorial Commentary: Acetabular Labral Repair-Is A Knotless Anchor Better? Arthroscopy. 2019 Jan;35(1):77-79. doi: 10.1016/j.arthro.2018.09.003.
- Background: PubMed 36395962Carbone AD, Prabhavalkar O, Chishti Z, Curley AJ, Parsa A, Domb BG. Hip Capsular Repair Results in Improved Patient-Reported Outcomes and Survivorship: A Systematic Review of the Literature. Arthroscopy. 2023 Feb;39(2):488-497. doi: 10.1016/j.arthro.2022.11.013. Epub 2022 Nov 14.
- Background: PubMed 29349029Conaway WK, Martin SD. Puncture Capsulotomy During Hip Arthroscopy for Femoroacetabular Impingement: Preserving Anatomy and Biomechanics. Arthrosc Tech. 2017 Nov 27;6(6):e2265-e2269. doi: 10.1016/j.eats.2017.08.036. eCollection 2017 Dec.
- Background: PubMed 31798933Beck EC, Cvetanovich GL, Levy DM, Weber AE, Kuhns BD, Khair MM, Rasio J, Nho SJ. A T-capsulotomy provides increased hip joint visualization compared with an extended interportal capsulotomy: commentary response. J Hip Preserv Surg. 2019 Nov 23;6(3):290-291. doi: 10.1093/jhps/hnz043. eCollection 2019 Aug. No abstract available.
- Background: PubMed 29373289Domb BG, Chaharbakhshi EO, Perets I, Walsh JP, Yuen LC, Ashberg LJ. Patient-Reported Outcomes of Capsular Repair Versus Capsulotomy in Patients Undergoing Hip Arthroscopy: Minimum 5-Year Follow-up-A Matched Comparison Study. Arthroscopy. 2018 Mar;34(3):853-863.e1. doi: 10.1016/j.arthro.2017.10.019. Epub 2018 Jan 17.
- Background: PubMed 31891553Economopoulos KJ, Chhabra A, Kweon C. Prospective Randomized Comparison of Capsular Management Techniques During Hip Arthroscopy. Am J Sports Med. 2020 Feb;48(2):395-402. doi: 10.1177/0363546519894301. Epub 2019 Dec 31.
- Background: PubMed 34403279Looney AM, McCann JA, Connolly PT, Comfort SM, Curley AJ, Postma WF. Routine Capsular Closure With Hip Arthroscopic Surgery Results in Superior Outcomes: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Jun;50(7):2007-2022. doi: 10.1177/03635465211023508. Epub 2021 Aug 17.
- Background: PubMed 30906690Monroe EJ, Chambers CC, Zhang AL. Periportal Capsulotomy: A Technique for Limited Violation of the Hip Capsule During Arthroscopy for Femoroacetabular Impingement. Arthrosc Tech. 2019 Jan 28;8(2):e205-e208. doi: 10.1016/j.eats.2018.10.015. eCollection 2019 Feb.
- Background: PubMed 28866345Ortiz-Declet V, Mu B, Chen AW, Litrenta J, Perets I, Yuen LC, Domb BG. Should the Capsule Be Repaired or Plicated After Hip Arthroscopy for Labral Tears Associated With Femoroacetabular Impingement or Instability? A Systematic Review. Arthroscopy. 2018 Jan;34(1):303-318. doi: 10.1016/j.arthro.2017.06.030. Epub 2017 Aug 31.
- Background: PubMed 32015889Radha S, Hutt J, Lall A, Domb B, Lynch TS, Griffin D, Field RE, Chuck-Cakic J. Best practice guidelines for arthroscopic intervention in femoroacetabular impingement syndrome: results from an International Delphi Consensus Project-Phase 1. J Hip Preserv Surg. 2019 Dec 16;6(4):326-338. doi: 10.1093/jhps/hnz055. eCollection 2019 Dec.
- Background: PubMed 24162717Willimon SC, Briggs KK, Philippon MJ. Intra-articular adhesions following hip arthroscopy: a risk factor analysis. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):822-5. doi: 10.1007/s00167-013-2728-0. Epub 2013 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LoopLoc Arm in people with Femoro Acetabular Impingement, run by American Hip Institute 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Jan 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Mantice (8338724477, alexandra.mantice@americanhipinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Harris Hip Score (time frame: 2 years). 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 NCT06500364, 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 1 Jan 2025.