Modeling and Workflow Recognition for the Anterior Approach in Total Hip Arthroplasty

NCT ID: NCT05993845

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

BACKGROUND AND PROJECT RATIONALE

In Total Hip Arthroplasty (THA), a degenerated hip joint is replaced with an artificial acetabular and femoral component. In clinical practice, several approaches to accessing bone anatomy are employed. The direct anterior approach (DAA) has been adopted widely in recent years due to smaller incisions, fewer complications, faster recovery, and improved patient outcomes. However, the reduced space and limited access may cause more complexity in the execution of surgical steps.

Primary objective

The first goal of this project is to create a systematic and general description of the surgical process for DAA in THA. For this purpose, surgical process models (SPMs) provide a basis to manage, organize, and optimize the surgical process. For this purpose, a labeled dataset of THA surgery videos will be segmented into individual surgical steps and sub-steps using a systematic approach. SPMs are a simplified network of surgical or surgery-related activities and their relationships. These models can be used to compare several interventions, surgeons, or whole Operating Room teams. In addition, the SPMs can be used as input for workflow management systems.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Prosthesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Recording of total hip arthroplasty

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recording of total hip arthroplasty

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philipp Fürnstahl

OTHER

Sponsor Role lead

Kantonsspital Baden

OTHER

Sponsor Role collaborator

Kantonsspital Winterthur KSW

OTHER

Sponsor Role collaborator

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Philipp Fürnstahl

Prof. Dr. Sc., Assistant Professor in Orthopedic Computer Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Philipp Fürnstahl, PhD

Role: PRINCIPAL_INVESTIGATOR

Balgrist University Hospital

Patrick Zingg, MD

Role: STUDY_CHAIR

Balgrist University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kantonsspital Baden

Baden, Canton of Aargau, Switzerland

Site Status NOT_YET_RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Site Status NOT_YET_RECRUITING

Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicola Cavalcanti, MD

Role: CONTACT

+41445107379

Matthias Seibold, PhD

Role: CONTACT

P +41 44 510 73 57

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nicola Cavalcanti, MD

Role: primary

+41445107379

Nicola Cavalcanti

Role: primary

+41445107379

Nicola Cavalcanti, MD

Role: primary

+41445107379

Matthias Seibold, PhD

Role: backup

+41 44 510 73 57

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35145990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32057597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34774686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18952942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31076194 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

W1018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pre-Op THA Modelling
NCT05221554 RECRUITING NA