Hip InjuriesNCT02990234
Capsular Repair in FAI Impingement Surgery
A study testing Capsular Repair and No Capsular Repair in people with Hip Injuries, run by University of Colorado, Denver.
Trial summary
The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. Read more about this study
- Who is it for?
- Ages 16 to 51 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- Capsular Repair and No Capsular Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2017
- 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 16 to 51 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients aged between 16-51 years of age.
- Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
- No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
- No previous hip surgery
- No other influential disabilities in lower limbs
- No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
- Base line activity level (Tegner 3 and above)
Who cannot join
- Patients with concomitant disease that may affect joints
- Patients with major ligamentous laxity
- Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
- Patients with extreme range of motion needs (such as ballet dancers)
- Patients suffering from connective tissue disease
- Patients suffering from bilateral symptomatic FAI that are being operated on for their first hip
Show all 12Show fewer
- Patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
- Patients who needed Ilio-Psoas release
- Patients whose cartilage hip status was defined as advanced OA during surgery
- Patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks
- Concomitant use of PRP (platelet rich plasma) or hyaluronic acid during the surgical procedure
- Patients with preoperative hip stiffness
About this study
Official title: The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular
The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. The objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. Secondary objective is to evaluate radiographic characteristics between both groups.
- Conditions
- Hip Injuries
- Being tested
- Capsular Repair, No Capsular Repair
- Keywords
- Capsular Repair, FAI, Hip
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsular RepairProcedure or surgery
No Capsular RepairProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Capsular Repair | Active comparator | Capsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not. Receives: Procedure: Capsular Repair |
| No Capsular Repair | Placebo comparator | Placebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair. Receives: Procedure: No Capsular Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in iHOT Version 12
Measured: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startMar 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip InjuriesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Mei-Dan, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990234
- Sponsor's protocol ID
- 13-2310
- Status last verified
- Nov 2017
- First submitted
- 5 Dec 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bowman KF Jr, Fox J, Sekiya JK. A clinically relevant review of hip biomechanics. Arthroscopy. 2010 Aug;26(8):1118-29. doi: 10.1016/j.arthro.2010.01.027.
PubMed 20678712Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.
PubMed 16822891Philippon MJ, Schenker ML. Arthroscopy for the treatment of femoroacetabular impingement in the athlete. Clin Sports Med. 2006 Apr;25(2):299-308, ix. doi: 10.1016/j.csm.2005.12.006.
PubMed 16638493Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
PubMed 16376242Ranawat AS, McClincy M, Sekiya JK. Anterior dislocation of the hip after arthroscopy in a patient with capsular laxity of the hip. A case report. J Bone Joint Surg Am. 2009 Jan;91(1):192-7. doi: 10.2106/JBJS.G.01367. No abstract available.
PubMed 19122095Matsuda DK. Acute iatrogenic dislocation following hip impingement arthroscopic surgery. Arthroscopy. 2009 Apr;25(4):400-4. doi: 10.1016/j.arthro.2008.12.011. Epub 2009 Feb 1.
PubMed 19341927Benali Y, Katthagen BD. Hip subluxation as a complication of arthroscopic debridement. Arthroscopy. 2009 Apr;25(4):405-7. doi: 10.1016/j.arthro.2009.01.012.
PubMed 19341928Ilizaliturri VM Jr, Byrd JW, Sampson TG, Guanche CA, Philippon MJ, Kelly BT, Dienst M, Mardones R, Shonnard P, Larson CM. A geographic zone method to describe intra-articular pathology in hip arthroscopy: cadaveric study and preliminary report. Arthroscopy. 2008 May;24(5):534-9. doi: 10.1016/j.arthro.2007.11.019. Epub 2008 Feb 1.
PubMed 18442685
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Capsular Repair in Arthroscopic Femoroacetabular
- ClinicalTrials.gov ID
- NCT02990234
- Acronym / sponsor ID
- 13-2310
- Conditions
- Hip Injuries
- Keywords
- Capsular Repair, FAI, Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Dec 2016 (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.
The Investigator's hypothesis is that capsular repair (after CAM or mixed Femoroacetabular Impingement (FAI) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. The objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. Secondary objective is to evaluate radiographic characteristics between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsular Repair | Active comparator | Procedure: Capsular RepairCapsular Repair arm. The first hip is randomized, opposite treatment on second hip. One Hip will receive the capsular repair while the other hip will not. |
| No Capsular Repair | Placebo comparator | Procedure: No Capsular RepairPlacebo arm. One hip is randomized to capsular repair while the other hip has no capsular repair. |
Who may qualify
- Ages
- 16 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female patients aged between 16-51 years of age.
- Healthy patients undergoing hip arthroscopy due to Cam or mixed FAI
- No major osteoarthritic (OA) changes according to X-Ray and surgery observation (Tonnis 0-1)
- No previous hip surgery
- No other influential disabilities in lower limbs
Key exclusion criteria (12 listed)
- Patients with concomitant disease that may affect joints
- Patients with major ligamentous laxity
- Patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions)
- Patients with extreme range of motion needs (such as ballet dancers)
- Patients suffering from connective tissue disease
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 |
|---|---|---|
| Capsular Repair | Procedure or surgery | Capsular Repair |
| No Capsular Repair | Procedure or surgery | No Capsular Repair |
Primary outcome
Change in iHOT Version 12
Time frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years
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 2 Dec 2017.
- Background: PubMed 20678712Bowman KF Jr, Fox J, Sekiya JK. A clinically relevant review of hip biomechanics. Arthroscopy. 2010 Aug;26(8):1118-29. doi: 10.1016/j.arthro.2010.01.027.
- Background: PubMed 16822891Byrd JW. Hip arthroscopy. J Am Acad Orthop Surg. 2006 Jul;14(7):433-44. doi: 10.5435/00124635-200607000-00006. No abstract available.
- Background: PubMed 16638493Philippon MJ, Schenker ML. Arthroscopy for the treatment of femoroacetabular impingement in the athlete. Clin Sports Med. 2006 Apr;25(2):299-308, ix. doi: 10.1016/j.csm.2005.12.006.
- Background: PubMed 16376242Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
- Background: PubMed 19122095Ranawat AS, McClincy M, Sekiya JK. Anterior dislocation of the hip after arthroscopy in a patient with capsular laxity of the hip. A case report. J Bone Joint Surg Am. 2009 Jan;91(1):192-7. doi: 10.2106/JBJS.G.01367. No abstract available.
- Background: PubMed 19341927Matsuda DK. Acute iatrogenic dislocation following hip impingement arthroscopic surgery. Arthroscopy. 2009 Apr;25(4):400-4. doi: 10.1016/j.arthro.2008.12.011. Epub 2009 Feb 1.
- Background: PubMed 19341928Benali Y, Katthagen BD. Hip subluxation as a complication of arthroscopic debridement. Arthroscopy. 2009 Apr;25(4):405-7. doi: 10.1016/j.arthro.2009.01.012.
- Background: PubMed 18442685Ilizaliturri VM Jr, Byrd JW, Sampson TG, Guanche CA, Philippon MJ, Kelly BT, Dienst M, Mardones R, Shonnard P, Larson CM. A geographic zone method to describe intra-articular pathology in hip arthroscopy: cadaveric study and preliminary report. Arthroscopy. 2008 May;24(5):534-9. doi: 10.1016/j.arthro.2007.11.019. Epub 2008 Feb 1.
- 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.
Omer Mei-Dan, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Capsular Repair and No Capsular Repair in people with Hip Injuries, run by University of Colorado, Denver.
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 7 inclusion and 12 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in iHOT Version 12 (time frame: Baseline, 6weeks, 12weeks, 6months, 1Year, 2Years). 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 NCT02990234, which also lists 8 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 2 Dec 2017.