Skip to content

Clinical Investigation of "Femur First Workflow" for computer-assisted navigation in total hip arthroplasty

Clinical Investigation of "Femur First Workflow" for computer-assisted navigation in total hip arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000739
Enrollment
133
Registered
2011-05-02
Start date
2011-06-16
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M16.1 M16.3 M16.5 M16.7 M16.9

Interventions

Group 1: Navigation assisted placement of primary Hip Total Endoprosthesis Group 2: Conventional placement of primary Hip Total Endoprosthesis

Sponsors

Brainlab AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: • Indication for total hip arthroplasty due to coxarthrosis • Physical condition to receive total hip arthroplasty; • Patient consent to study procedures (incl. post-operative CT)

Exclusion criteria

Exclusion criteria: • Patient age 75; • Hip implant present on the contralateral side; • Termination of navigated procedure due to technical difficulties

Design outcomes

Primary

MeasureTime frame
Approx. 6-8 weeks postoperatively, a pelvic/femoral CT scan will be perfomed. Then, the postoperative range-of-motion/ROM of the treated hip joint until bony or metal impingement will be determined. For this purpose, the bone structures will be segmented in the post-operative CT data set. Based on the segmented bone models, the postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements.

Secondary

MeasureTime frame
Based on a postoperative CT scan of the hip and femur, additional evaluation will be performed. The variability of the cup position using conventional or computer-assisted implantation will be analyzed by measuring the cup position in the post-operative CT data sets. The accuracy of the image-free navigation procedure for cup and shaft placement will be assessed by comparing the intraoperatively acquired implant positions with measurements in the postoperative CT data. A pre- and post-operative clinical examination including various scores for total hip arthroplasty (Harris Hip Score, HOOS etc.), life quality (SF 36, EuroQol), and pain (visual analog scale 1-10) will be used. A pre- and post-operative (6 months-1 year)gait analysis using a gait laboratory and a musculoskeletal model will be performed for a subset of patients (40-60). Hip reaction forces, hip angle variation, implant-bone contact stress and muscle forces/activation will be evaluated with the help of the AnyBody Managed Model Repository (AMMR 2009). In order to apply motion to the model marker position trajectories of gait laboratory experiments are used.

Countries

Germany

Contacts

Public ContactTobias Renkawitz

Orthopädische Klinik für die Universität Regensburg, Asklepios Klinikum Bad Abbach

t.renkawitz@asklepios.com09405 180

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 28, 2026