NCT04265222

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

4.8 years

First QC Date

February 4, 2020

Last Update Submit

July 31, 2024

Conditions

Femoroacetabular Impingement

Keywords

OrthopedicsCam DecompressionFemoroplastyFemoroacetabular Impingement

Outcome Measures

Primary Outcomes (9)

  • modified Harris Hip Score

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

    1 year

  • Nonarthritic Hip Score

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

    1 year

  • International Hip Outcome Tool-12

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

    1 year

  • Short Form 12 Mental

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal mental outcome

    1 year

  • Short Form 12 Physical

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

    1 year

  • Veterans RAND 12-Item Health Survey Mental

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal mental outcome

    1 year

  • Veterans RAND 12-Item Health Survey Physical

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

    1 year

  • Patient satisfaction

    Patient-reported outcome measure. Scale 0-10, 10 indicating patient is extremely satisfied with surgery and met expectations.

    1 year

  • Visual Analog Pain Scale

    Patient-reported outcome measure. Scale 0-10, with 0 indicated no pain post-surgery.

    1 year

Secondary Outcomes (2)

  • Age

    before surgery

  • Body Mass Index, kg/m^2

    before surgery

Study Arms (2)

Conventional Fluoroscopy

OTHER

Participants undergoing femoroplasty with conventional treatment

Other: Conventional Fluoroscopy

HipCheck

EXPERIMENTAL

Participants undergoing femoroplasty with Stryker HipCheck System

Device: Hipcheck Software

Interventions

Hipcheck SoftwareDEVICE

Software

Also known as: Stryker HipCheck system
HipCheck
Conventional FluoroscopyOTHER

Conventional Fluoroscopy

Conventional Fluoroscopy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hip Institute

Des Plaines, Illinois, 60018, United States

Location

Related Publications (4)

  • Larson CM, Giveans MR, Samuelson KM, Stone RM, Bedi A. Arthroscopic Hip Revision Surgery for Residual Femoroacetabular Impingement (FAI): Surgical Outcomes Compared With a Matched Cohort After Primary Arthroscopic FAI Correction. Am J Sports Med. 2014 Aug;42(8):1785-90. doi: 10.1177/0363546514534181. Epub 2014 May 29.

    PMID: 24875469BACKGROUND

  • Mansor Y, Perets I, Close MR, Mu BH, Domb BG. In Search of the Spherical Femoroplasty: Cam Overresection Leads to Inferior Functional Scores Before and After Revision Hip Arthroscopic Surgery. Am J Sports Med. 2018 Jul;46(9):2061-2071. doi: 10.1177/0363546518779064. Epub 2018 Jun 20.

    PMID: 29924630BACKGROUND

  • Matsuda DK, Schnieder CP, Sehgal B. The critical corner of cam femoroacetabular impingement: clinical support of an emerging concept. Arthroscopy. 2014 May;30(5):575-80. doi: 10.1016/j.arthro.2014.01.009. Epub 2014 Mar 12.

    PMID: 24630123BACKGROUND

  • Ross JR, Larson CM, Adeoye O, Kelly BT, Bedi A. Residual deformity is the most common reason for revision hip arthroscopy: a three-dimensional CT study. Clin Orthop Relat Res. 2015 Apr;473(4):1388-95. doi: 10.1007/s11999-014-4069-9.

    PMID: 25475714BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ajay C Lall, MD, MS

    American Hip Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 11, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)