NCT05993845

Brief Summary

The purpose of this study is to create a systematic and general description of the surgical process for the direct anterior approach (DAA) in total hip arthroplasty (THA). For this purpose a surgical process model with a labeled dataset of THA surgery videos will be segmented into the individual surgical steps and sub-steps using a systematic approach.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

3 active sites

Status
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

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 23, 2025

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 7, 2023

Last Update Submit

January 21, 2025

Conditions

Keywords

Surgery RecordingArthroplastySurgical Process Modelling

Outcome Measures

Primary Outcomes (1)

  • labeled recordings of total hip arthroplasty

    Surgery recordings of Total Hip Arthroplasties (THA) with Direct Anterior Approach (DAA) performed at Balgrist University Hospital will be used to develop an in-depth systematic analysis of surgical workflows and activity. The comparison and evaluation of THA with DAA performed at two external hospitals (Kantonsspital Baden, Switzerland and Kantonsspital Winterthur, Switzerland) will allow to generalize and evaluate the developed models: Multicenter study.

    Up to 1 year

Other Outcomes (1)

  • automated deep learning-based approach for surgical workflow and activity recognition for total hip arthroplasty (THA)

    Up to 1 year

Study Arms (1)

Project population for total hip arthroplasty surgery recordings

We plan to record 60 total hip arthroplasty (THA) surgeries in the operating theatre performed by different surgeons of the hip team at Balgrist University Hospital or Kantonsspital Baden or Kantonsspital Winterthur, for data collection purposes.

Other: Recording of total hip arthroplasty

Interventions

We record total hip arthroplasties (THA) of hip surgeons at Balgrist University Hospital (BUH), Kantonsspital Baden (KSB), Kantonsspital Winterthur (KSW). Video \& audio data are stored locally at Balgrist-managed servers (patient-sensitive information removed). Data includes: Demographics (year of birth, sex, smoking status, body mass index) Diagnosis Surgery-specific data \& other surgical procedures during recording Standard preoperative Computed tomography of the hip/pelvis Standard pelvis x-rays pre- \& postoperative Standard axial hip x-rays pre- \& postoperative Western Ontario \& McMaster Universities Osteoarthritis Index \& Harris-Hip-Score To ensure the generated Surgical process model(SPM), evaluated using the recordings obtained from surgeries performed at BUH, generally describes the surgical process of THA, we apply our model to surgeries from the KSB and the KSW. There, 3 THAs are recorded and analyzed regarding commonalities and discrepancies in the SPM.

Project population for total hip arthroplasty surgery recordings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to record 60 THA surgeries in the operating room performed by different hip surgeons at Balgrist University Hospital, Kantonsspital Baden, or Kantonsspital Winterthur, for data collection. Patients are recruited if they fit the in-/exclusion criteria and get primary information from the surgeon as soon as the decision for surgery has been made in the outpatient clinic. The patients are handed a copy of the informed consent and can decide on participating until the follow-up consultation. The decision to perform the procedure is not linked to the study. The decision to participate does not affect the procedure itself.

You may qualify if:

  • Primary surgery for total hip arthroplasty (THA) at Balgrist University Hospital, Kantonsspital Baden and Kantonsspital Winterthur
  • Complete radiological data (CT and Hip/Pelvis x-ray)
  • Signed consent

You may not qualify if:

  • Missing or incomplete consent
  • Previous surgery of the hip at the site of the THA
  • Fracture of the hip or pelvis at the site of the THA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

NOT YET RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

NOT YET RECRUITING

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (7)

  • Carrillo F, Esfandiari H, Muller S, von Atzigen M, Massalimova A, Suter D, Laux CJ, Spirig JM, Farshad M, Furnstahl P. Surgical Process Modeling for Open Spinal Surgeries. Front Surg. 2022 Jan 25;8:776945. doi: 10.3389/fsurg.2021.776945. eCollection 2021.

    PMID: 35145990BACKGROUND
  • Charney M, Paxton EW, Stradiotto R, Lee JJ, Hinman AD, Sheth DS, Prentice HA. A Comparison of Risk of Dislocation and Cause-Specific Revision Between Direct Anterior and Posterior Approach Following Elective Cementless Total Hip Arthroplasty. J Arthroplasty. 2020 Jun;35(6):1651-1657. doi: 10.1016/j.arth.2020.01.033. Epub 2020 Jan 22.

    PMID: 32057597BACKGROUND
  • Haynes JA, Hopper RH Jr, Ho H, McDonald JF 3rd, Parks NL, Hamilton WG. Direct Anterior Approach for Primary Total Hip Arthroplasty Lowers the Risk of Dislocation Compared to the Posterior Approach: A Single Institution Experience. J Arthroplasty. 2022 Mar;37(3):495-500. doi: 10.1016/j.arth.2021.11.011. Epub 2021 Nov 10.

    PMID: 34774686BACKGROUND
  • Neumuth T, Jannin P, Strauss G, Meixensberger J, Burgert O. Validation of knowledge acquisition for surgical process models. J Am Med Inform Assoc. 2009 Jan-Feb;16(1):72-80. doi: 10.1197/jamia.M2748. Epub 2008 Oct 24.

    PMID: 18952942BACKGROUND
  • Patel NN, Shah JA, Erens GA. Current Trends in Clinical Practice for the Direct Anterior Approach Total Hip Arthroplasty. J Arthroplasty. 2019 Sep;34(9):1987-1993.e3. doi: 10.1016/j.arth.2019.04.025. Epub 2019 Apr 18.

    PMID: 31076194BACKGROUND
  • Seibold, M., Hoch, A., Farshad, M., Navab, N., & Fürnstahl, P. (2022). Conditional generative data augmentation for clinical audio datasets. Medical Image Computing and Computer Assisted Intervention (MICCAI). Singapore.

    BACKGROUND
  • Zisimopoulos, O., Flouty, E., Luengo, I., Giataganas, P., Nehme, J., Chow, A., & Stoyanov, D. (2018). DeepPhase: Surgical Phase Recognition in CATARACTS Videos. Lecture Notes in Computer Science (including subseries Lecture Notes in Artificial, 11073, 265-275.

    BACKGROUND

Study Officials

  • Philipp Fürnstahl, PhD

    Balgrist University Hospital

    PRINCIPAL INVESTIGATOR
  • Patrick Zingg, MD

    Balgrist University Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Sc., Assistant Professor in Orthopedic Computer Science

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

October 30, 2024

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

January 23, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The individual participant data will only be shared in an anonymized form upon reasonable request after the project has been completed and the data has been published as a scientific article.

Locations