Cam Decompression Utilizing the Stryker Hip-Check Software Platform
Cam Decompression Utilizing the Stryker Hip-Check Software Platform
Accurate femoroplasty has been shown to be critical in achieving success following treatment
 of femoroacetabular impingement (Matsuda, Schnieder, and Sehgal 2014; Mansor et al. 2018;
 Larson et al. 2014). Nearly 75% of cases undergoing revision hip arthroscopy do so due to
 residual femoroacetabular impingement (Ricciardi et al. 2014). Femoroplasty remains one of
 the most challenging and time-consuming procedures in hip arthroscopy and methods to improve
 accuracy and optimize time management are essential. The HipCheck system is a navigational
 tool based on intraoperative fluoroscopy that aims at improving accuracy and efficiency of
 femoroplasty.

 The objective of this study is to two-fold. (1) To prospectively compare surgical and (2)
 radiographic outcomes of patients undergoing femoroplasty with guidance of Stryker's HipCheck
 system to patients undergoing femoroplasty with conventional fluoroscopic methods.
The purpose of this study is to prospectively compare surgical and radiographic outcomes of
 patients undergoing femoroplasty with guidance of Stryker's HipCheck system to patients
 undergoing femoroplasty with conventional fluoroscopic methods.

 Endpoints:

 Time from initiation to completion of femoroplasty Accuracy of femoroplasty as determined by:
 alpha angle on Dunn view and AP view, femoral head offset, and area of over resection and
 under resection Fluoroscopic exposure (microgray and seconds) Post-operative opioid
 consumption/medication use

 Basic design: Randomized Controlled Study

 Participants: 40 patients 20 patients will undergo femoroplasty with the conventional
 technique 20 patients will undergo femoroplasty with the HipCheck system

 Accurate femoroplasty has been shown to be critical in achieving success following treatment
 of femoroacetabular impingement (FAI).1-3 Nearly 75% of cases undergoing revision hip
 arthroscopy do so due to residual FAI. Matsuda et al. coined the term "critical corner" to
 describe residual impingement not resected during routine anterolateral femoroplasty. These
 residual cam lesions have been shown to lead to inferior outcomes and are commonly implicated
 in revision hip arthroscopies. These studies and others contributed to the development of the
 "spherical femoroplasty" as an attempt to minimize residual cam lesions while simultaneously,
 avoiding over-resection. Femoroplasty remains one of the most challenging and time-consuming
 procedures in hip arthroscopy and methods to improve accuracy and optimize time management
 are essential.

 General Schema of Study Design Overview Patients will be randomly assigned to undergo
 femoroplasty either with a conventional technique or a navigational method involving the
 HipCheck system. Preoperatively, the patient will undergo a series of standard radiographs to
 assess the degree of deformity. At this time, ROM will also be assessed. During surgery time
 required for femoroplasty as well as total fluoroscopic exposure time, as well as total
 exposure in microgray will be recorded. At 2 weeks postoperatively patient will undergo a
 series of standard radiographs to assess accuracy of femoroplasty. Narcotic medication use,
 pain levels and patient-reported outcome scores (PROs) will be assessed at 2 weeks, 3 months,
 6 months, and 12 months postoperatively. A clinical exam will be performed postoperatively at
 each visit, consisting of hip range of motion (internal/external rotation, flexion,
 abduction, and adduction) with the patient in the supine position, impingement tests, and
 gait. Radiographic measurements will be performed using the institutional PACS system as well
 as ImageJ for surface area calculations. The patients as well as the clinician performing
 postoperative radiographic calculations will be blinded to method of treatment.

 The total duration of the study is 1 year and 6 months:

 Legal contract & IRB review: 8 weeks Patients recruitment/procedure: 8 weeks Follow up
 period: 1 year Manuscript writing/submission: 8 weeks

 Data Sources Research resources: Research data will be collected and recorded by study
 personnel designated by the Investigator.

 Study Procedures

 Pre-Operative A series of standard radiographs (Dunn, AP, False profile views) will be taken
 to understand the severity of the cam-type impingement. A clinical exam including but not
 limited to the following will be performed: gait (antalgic, Trendelenburg) hip range of
 motion (internal/external rotation, flexion, abduction, and adduction) with the patient in
 the supine position; anterior, posterior and lateral impingement tests; painful
 internal/external snapping test, FABER's test, Modified Resisted Internal rotation test,
 Ligamentum Teres test.

 Pre-operative patient-reported outcome scores (PROs) and Visual Analog Pain Scale (VAS) will
 be taken during screening. The PROs include: mHHS, modified Harris Hip Score; NAHS,
 Nonarthritic Hip Score; iHOT-12, International Hip Outcome Tool; SF-12M, Short Form 12
 Mental; SF-12P, Short Form 12-Physical; VR-12M, Veterans RAND 12-Item Health Survey Mental;
 VR-12P, Veterans RAND 12-Item Health Survey Physical; and Patient satisfaction (out of 10).

 Intra-Operative During surgery - time required for femoroplasty as well as total fluoroscopic
 exposure time, as well as total exposure in microgray will be recorded. Procedural start (at
 initiation of femoroplasty) and finish (at completion of femoroplasty) time will be recorded
 for comparative analysis of both groups. Fluoroscopic exposure time and total exposure in
 microgray will be determined based on total number of shots taken and known
 duration/microgray exposure of each fluoroscopic shot. Fluoroscopic shot duration/Microgray
 exposure: mean total fluoroscopy time will be limited to 1.10 minutes or less (52 mGy or less
 per patient), based on recommendations by Budd et al. 2012

 Intraoperative Fluoroscopic Image Acquisition Each patient will be placed in a neutral
 position to allow for the standardization and comparison with the well-centered, preoperative
 anteroposterior (AP) pelvic radiographs that are typically used for structural analysis and
 treatment planning.

 Once the fluoroscopic image most closely replicates the AP pelvis, the femoral head-neck
 junction (FHNJ) will be assessed with fluoroscopy, with the leg in 6 different positions and
 fluoroscopic C-arm in 3 different positions (see table below) that allow for the evaluation
 of the medial and lateral FHNJ (extension views) and anterior and posterior FHNJ (flexion
 views). These views will be obtained by rotating the operative distal femur,
 flexing/extending the operative hip, and/or adducting the operative hip.

 For all six positions, the angle of rotation will be verified with a Goniometer (Prestige
 Medical, Northridge, CA).

 Measurements of the alpha angle will be performed by a single reader on each exported
 fluoroscopic view (corresponding to the six positions) for every control specimen with the
 use of the HipCheck System. For the control group the surgeon will review the fluoroscopic
 images prior to the resection procedure, but without making or reviewing any measurements or
 analysis (The HipCheck analysis platform will have "alpha angle overlay" turned off, to keep
 measurements from being displayed). For the HipCheck group the surgeon will review the
 fluoroscopic images including the HipCheck analysis for each view prior to resection.

 Hip Arthroscopy (femoroplasty):

 Femoroplasty will be performed using a 5.5 mm bur. This will be done in combination with the
 aid of fluoroscopic visualization and HipCheck technology or isolated fluoroscopic
 visualization, depending on the patient group assignment.

 The HipCheck system will be used intraoperatively to assist with clinical decision making by
 assessing and providing feedback on alpha angle and confirming complete bony resection and
 absence of residual deformity for the test group only. To prevent over- or under resection,
 HipCheck provides a resection line (spline) for the surgeon to visualize and resect the
 desired amount, with a target alpha angle of 40 degrees.

 The control group will not receive intra-operative assistance from the HipCheck software
 platform. Both arthroscopic and fluoroscopic imaging will be used to identify the cam and aid
 in resection per the standard hip arthroscopy technique.

 "Postoperative" Fluoroscopic Image Acquisition At the conclusion of the hip arthroscopy,
 postoperative fluoroscopy views will be obtained with the same six leg positions. The angle
 of rotation will be verified with a Goniometer (Prestige Medical, Northridge, CA). The
 HipCheck tablet and software may be used to capture and later analyze the alpha angle for
 each of these leg positions for both the control and test groups.

 Post-Operative At 2 weeks postoperatively patients will undergo a series of standard
 radiographs (Dunn, AP, False profile views) to assess accuracy of femoroplasty. Measurements
 will be performed using the institutional PACS system as well as ImageJ for surface area
 calculations. Accuracy of femoroplasty will be determined by: alpha angle on Dunn, AP views
 and false profile, femoral head offset, and area of over resection and under resection on AP.
 The patients as well as the clinician performing postoperative radiographic calculations will
 be blinded to method of treatment. A post-operative PROs and VAS Pain Score will be taken at
 2 weeks, 3 months, 6 months, and 12 months post-operatively. Medication use will be
 documented in post-op recovery, at 2 weeks, 3months, and 12 months post-operatively. A
 clinical exam including range of motion assessment will be performed at 2-week, 3-, 6-, and
 12-month follow-up visits.

 Subject Inclusion Criteria

 Candidates for this study must meet ALL of the following criteria:

 1. Patients undergoing hip arthroscopy; aged 18-50 years old.

 2. Radiographic evidence of a cam lesion as defined by an alpha angle greater than 60
 degrees as measured on the Dunn X-ray.

 3. Failure of non-conservative management

 Subject Exclusion Criteria

 Candidates will be excluded from the study if ANY of the following apply:

 1. Unwilling to participate

 2. History of prior hip conditions such as slipped capital femoral epiphysis,
 Legg-Calvé-Perthes disease, idiopathic avascular necrosis, hip joint trauma, and prior
 hip surgeries

 3. The presence of a concurrent systemic inflammatory arthritis such as rheumatoid
 arthritis; psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis,
 or systemic lupus erythematosus

 4. Marked osteoarthritis (Tönnis grade 2 or higher)

 5. Subject is considered a part of a vulnerable population

 6. Pregnancy in order to avoid: x-rays and the contraindication of lying supine after 20
 weeks secondary to pressure on the abdominal aorta

 Subject Withdrawal Criteria Subjects may voluntarily withdraw from the study at any time for
 any reason. The Investigator may elect at any time to withdraw a subject from the study for
 any reason if such a decision is in the subject's best medical interest. If a patient
 discontinues the study or is withdrawn by the Investigator prior to surgery, the patient will
 not be counted as a completed subject and an additional subject may be enrolled to achieve
 the enrollment goal of 40 completed subjects.

 Data Management Use established data registry and collection methodology. All preoperative
 and demographic data is collected and inputted into registry preoperatively. Intraoperative
 data and measurements are collected and inputted at time of surgery. Postoperative
 radiographic measurements to assess alpha angle and combined femoral offset are made within 3
 months postoperatively, using a 2nd independent reader to verify inter- and intra-observer
 reliability.

 Intraoperative data and postoperative complications are collected using OBERD system.

 Risks Generalized risks to surgical procedures are present, which include but are not limited
 to bleeding, infection, injury to surrounding structures such as blood vessels, nerves,
 tendons, and bone. In addition, risks specific to hip arthroscopy include those related to
 hip traction related issues such as numbness and parasthesias to the perineum or soft tissue
 compression related complications. Lastly, risk to radiation exposure is present, however, it
 is limited with the use of HipCheck, as continuous fluoroscopy is not needed.

 Benefits Enhanced verification of intraoperative cam resection via minimal fluoroscopic
 exposure. In addition, increased accuracy of cam resection with the goals of avoiding over or
 underresection, will thereby potentially improve patient outcomes following hip arthroscopy.
Inclusion Criteria:

 Candidates for this study must meet ALL of the following criteria:

 -  Patients undergoing hip arthroscopy; aged 18-50 years old

 -  Radiographic evidence of a cam lesion as defined by an alpha angle greater than 60
 degrees as measured on the Dunn X-ray.

 -  Failure of non-conservative management

 Exclusion Criteria:

 Candidates will be excluded from the study if ANY of the following apply:

 -  Unwilling to participate

 -  History of prior hip conditions such as slipped capital femoral epiphysis,
 Legg-Calve-Perthes disease, idiopathic avascular necrosis, hip joint trauma, and prior
 hip surgeries

 -  The presence of a concurrent systemic inflammatory arthritis such as rheumatoid
 arthritis; psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis,
 or systemic lupus erythematosus

 -  Marked osteoarthritis (Tönnis grade 2 or higher)

 -  Subject is considered a part of a vulnerable population

 -  Pregnancy in order to avoid: x-rays and the contraindication of lying supine after 20
 weeks secondary to pressure on the abdominal aorta