Labrum Injury of the Hip JointNCT06845735
Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure
A study testing Non-Absorbable Sutures and Absorbable Suture in people with Labrum Injury of the Hip Joint and Hip Arthroscopy, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Labrum Injury of the Hip Joint, Hip Arthroscopy, Femoroacetabular Impingement Syndrome
- What is being tested?
- Non-Absorbable Sutures and Absorbable Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 1 Jan 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age and older.
- Subject requiring surgical hip arthroscopic intervention for their hip pathology
Who cannot join
- Subjects less than 18 years of age.
- Subjects with any other medical problem precluding anesthesia or surgery.
- Unable to provide informed consent.
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
Missouri Orthopaedic Institute
Columbia, Missouri, 65201
Vicki Jones, MEd, CCRP, 573-882-7583, jonesvicki@health.missouri.edu
Steven F DeFroda, MD, MEng
About this study
Official title: Prospective Randomized Control Trial Comparing Absorbable Sutures to Non-Absorbable Sutures for Capsular Closures in Hip Arthroscopies
The study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in addition to the standard of care set of 9 questionnaires. The other major outcome will be any radiographic heterotrophic ossification at the 6-month follow-up time point.
Read the detailed description
- International Hip Outcome Tool-12 is a 33-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease.
- Modified Harris hip score is composed of 8 survey questions to determine gait, functionality and pain.
- The hip outcome score is 26 survey questions designed to asses the outcome of arthroscopic hip surgery for individuals with acetabular labral tears, including sports related questions and activities of daily living.
Standard of care questionnaires will be given at follow up clinic visits. They are the:
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
- PROMIS pain interference
- PROMIS Global Health
- Pain Visual Analog Scale
- Hip Single Assessment Numeric Evaluation (SANE)
- Modified Harris Hip Score
- Marx Activity Scale
- Tegner Activity Scale
- Surgical Satisfaction
These questionnaires will be given at preoperative, 6-week, 3-month, 6-month, 1 year, 2 years and any other follow-up visits in association with surgery.
Any Radiographic images taken as standard of care (SOC) (post-operative radiographs are SOC) will be used in the study to determine Radiographic Heterotroph Ossification (HO) at 6 Months.
- Being tested
- Non-Absorbable Sutures, Absorbable Suture
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Absorbable SuturesDevice
Non-Absorbable Sutures
Absorbable SutureDevice
Absorbable suture
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Suture | Active comparator | Absorbable suture Receives: Device: Absorbable Suture |
| Non-Absorbable Suture | Active comparator | Non-Absorbable Sutures Receives: Device: Non-Absorbable Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Hip Outcome Tool-12 (IHOT-12)
12-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease. Each of the 12 questions assess hip function and are scored from 0-100. 0 is a low score and 100 is high score indicating excellent function. The IHOT-12 is scored from taking the average of the 12 items of the tool and is scored 0-100, 0 being a low score and poor function and 100 being a high score indicating excellent function.
Measured: Preoperative to 12 months postoperative
Modified Harris Hip score
composed of 8 survey questions to determine gait, functionality and pain. Each question is scored with a separate scoring range. Higher scores indicate better function and less pain. The score is calculated by adding up the assigned points for each item, dividing by the max score (91), and multiplying by 100 to create a percentage. A higher score indicates a higher level of physical function, with 100% indicating full function.
Measured: Preoperative to 12 months postoperative
Hip Outcome Score (HOS)
28-item assessment that is divided into 2 subscales: activities of daily living (HOS-ADL;19 items) and sports-related activities (HOS-Sports;9 items).
Of the 2 subscales, each question contains five answer choices ranging from low function (score of 0) to high function (score of 4). The maximum score possible for the HOS-ADL is 68. A high score indicates high function, and a low score indicates low function.
The maximum score possible for the HOS-Sports is 36. A high score indicates high function, and a low score indicates low function.
Scores for each subscale range from 0% (least function) to 100% (most function). Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: Preoperative to 12 months postoperative
Secondary outcomes (1)
Rate of Radiographic Heterotrophic Ossification
Any radiographic heterotrophic ossification at the 6-month follow-up time point.
Measured: Evaluated at 6-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start22 Mar 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labrum Injury of the Hip JointStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven DeFroda, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845735
- Sponsor's protocol ID
- 2099469
- Status last verified
- May 2026
- First submitted
- 27 Jan 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Control Trial Comparing Absorbable Sutures to Non-Absorbable Sutures for Capsular Closures in Hip Arthroscopies
- ClinicalTrials.gov ID
- NCT06845735
- Acronym / sponsor ID
- 2099469
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 25 Feb 2025 (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 study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in addition to the standard of care set of 9 questionnaires. The other major outcome will be any radiographic heterotrophic ossification at the 6-month follow-up time point.
Detailed description
- International Hip Outcome Tool-12 is a 33-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease.
- Modified Harris hip score is composed of 8 survey questions to determine gait, functionality and pain.
- The hip outcome score is 26 survey questions designed to asses the outcome of arthroscopic hip surgery for individuals with acetabular labral tears, including sports related questions and activities of daily living.
Standard of care questionnaires will be given at follow up clinic visits. They are the:
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
- PROMIS pain interference
- PROMIS Global Health
- Pain Visual Analog Scale
- Hip Single Assessment Numeric Evaluation (SANE)
- Modified Harris Hip Score
- Marx Activity Scale
- Tegner Activity Scale
- Surgical Satisfaction
These questionnaires will be given at preoperative, 6-week, 3-month, 6-month, 1 year, 2 years and any other follow-up visits in association with surgery.
Any Radiographic images taken as standard of care (SOC) (post-operative radiographs are SOC) will be used in the study to determine Radiographic Heterotroph Ossification (HO) at 6 Months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable Suture | Active comparator | Device: Absorbable SutureAbsorbable suture |
| Non-Absorbable Suture | Active comparator | Device: Non-Absorbable SuturesNon-Absorbable Sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects 18 years of age and older.
- Subject requiring surgical hip arthroscopic intervention for their hip pathology
Key exclusion criteria (3 listed)
- Subjects less than 18 years of age.
- Subjects with any other medical problem precluding anesthesia or surgery.
- Unable to provide informed consent.
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 |
|---|---|---|
| Non-Absorbable SuturesNon-Absorbable Sutures | Device | Non-Absorbable Suture |
| Absorbable SutureAbsorbable suture | Device | Absorbable Suture |
Primary outcome
International Hip Outcome Tool-12 (IHOT-12)
Time frame: Preoperative to 12 months postoperative
12-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease. Each of the 12 questions assess hip function and are scored from 0-100. 0 is a low score and 100 is high score indicating excellent function. The IHOT-12 is scored from taking the average of the 12 items of the tool and is scored 0-100, 0 being a low score and poor function and 100 being a high score indicating excellent function.
Modified Harris Hip score
Time frame: Preoperative to 12 months postoperative
composed of 8 survey questions to determine gait, functionality and pain. Each question is scored with a separate scoring range. Higher scores indicate better function and less pain. The score is calculated by adding up the assigned points for each item, dividing by the max score (91), and multiplying by 100 to create a percentage. A higher score indicates a higher level of physical function, with 100% indicating full function.
Hip Outcome Score (HOS)
Time frame: Preoperative to 12 months postoperative
28-item assessment that is divided into 2 subscales: activities of daily living (HOS-ADL;19 items) and sports-related activities (HOS-Sports;9 items). Of the 2 subscales, each question contains five answer choices ranging from low function (score of 0) to high function (score of 4). The maximum score possible for the HOS-ADL is 68. A high score indicates high function, and a low score indicates low function. The maximum score possible for the HOS-Sports is 36. A high score indicates high function, and a low score indicates low function. Scores for each subscale range from 0% (least function) to 100% (most function). Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
1 secondary outcome
Rate of Radiographic Heterotrophic Ossification
Time frame: Evaluated at 6-months postoperatively
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 10 Aug 2026.
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Osteoarthritis, Femoroacetabular Impingement Syndrome
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 study testing Non-Absorbable Sutures and Absorbable Suture in people with Labrum Injury of the Hip Joint and Hip Arthroscopy, run by University of Missouri-Columbia 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 2 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 10 Aug 2026. 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?
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 Vicki Jones, MEd, CCRP (573-882-7583, jonesvicki@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Hip Outcome Tool-12 (IHOT-12) (time frame: Preoperative to 12 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.