ClinicalTrials.gg
TerminatedNCT02499523Updated Mar 28, 2017

Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides

An interventional study of THR with conventional technique and THR with Acetabular Cup Orientation Guides (ACOG) in Osteoarthritis, Hip, sponsored by Materialise. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by Materialise · Not applicable, Interventional, and Treatment

Why this study was terminated
Low recruitment rate

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2014, registered Jul 2015).

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Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Osteoarthritis, Hip with a site in Belgium — 2 open to participants now, 4 under way, none of them phase 3. Osteoarthritis, Hip · Belgium.

Started
2014
the only one that year
No phase
5 of 15
1 open now
Registered
4th of 15
by date
Lead sponsor
1 of 15
Materialise

Among the 15 studies in Osteoarthritis, Hip with a site in Belgium, this one is the only one that started in 2014, is one of 5 with no phase, and was the 4th registered.

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

Browse Osteoarthritis, Hip studies →

Open to participants now

2 of the 15 studies in Osteoarthritis, Hip with a site in Belgium are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 87 Osteoarthritis, Hip studies recruiting now, 54 (62%) set no upper age limit and 7 (8%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Osteoarthritis, Hip with a site in Belgium, or all of them as a file.
02

Study summary

A prospective, interventional, monocentric, controlled and randomized study will compare a conventional surgical technique to a surgical technique with the assistance of the Acetabular Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).

Read the detailed description

Background: The Acetabular Cup Orientation Guide(ACOG) System from MATERIALISE NV was developed and is intended to be used as a surgical instrument to assist in the positioning of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative computed tomography (CT) imaging scans.

Use of ACOG is a relative new technique. ACOG, based on CT imaging data, fit directly into the patient's anatomy and enable primary total hip replacement . Data showing extra benefit of this technique compared to conventional THR technique are not widely available.

Aim: To determine the safety of this new surgical technique compared to conventional THR.

Methods: 30 participants will be randomized to 2 groups. One group will be operated for a THR with the conventional technique and the other group will be operated for a THR with the assistance of the ACOG System. CT imaging will be taken pre and post operatively to measure cup orientation.

03

Conditions studied

  • Osteoarthritis, Hip

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Is selected to undergo a primary THR

Exclusion criteria

Exclusion Criteria:

  • Is unable to undergo CT imaging of the full pelvis
  • Requires surgical treatment within less than 4 weeks of initiation
  • Is unable to undergo a THR through a anterolateral approach
  • Presents acute/chronic local or systemic infection
  • Is allergic to polyamide
  • Patient's > 35
  • Patients with severe wear of the acetabular rim or other disorders that affect acetabular rim anatomy and bony landmark recognition.Patients exhibiting severe wear.
  • Has impaired decision-making capacity
  • Is a prisoner
  • Is pregnant
  • Has metal components that will result in scatter on the CT imaging
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
7 participants (actual)

Study arms

  • Active comparator
    THR with conventional technique

    Use of conventional technique in THR

    Procedure: THR with conventional technique

  • Experimental
    THR with ACOG

    THR with Acetabular Cup Orientation Guides (ACOG)

    Procedure: THR with Acetabular Cup Orientation Guides (ACOG)

Interventions

  • ProcedureTHR with conventional technique

    THR with conventional technique.

  • ProcedureTHR with Acetabular Cup Orientation Guides (ACOG)

    THR with the ACOG System.

    Also known as: ACOG, Materialise

06

What researchers measure

Primary outcomes

  1. Acetabular cup positioning

    Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.

    Time frame: 2 Months post-operatively

Secondary outcomes

  1. Surgery time

    Time frame: 1 day

  2. Acetabular cup size

    Time frame: 2 months

07

Study locations

1 site
  • AZ Monica
    Antwerpen, 2018, Belgium
08

References and documents

Publications

  • Hananouchi T, Saito M, Koyama T, Hagio K, Murase T, Sugano N, Yoshikawa H. Tailor-made surgical guide based on rapid prototyping technique for cup insertion in total hip arthroplasty. Int J Med Robot. 2009 Jun;5(2):164-9. doi: 10.1002/rcs.243. PubMed 19248055 ↗
  • Hananouchi T, Saito M, Koyama T, Sugano N, Yoshikawa H. Tailor-made Surgical Guide Reduces Incidence of Outliers of Cup Placement. Clin Orthop Relat Res. 2010 Apr;468(4):1088-95. doi: 10.1007/s11999-009-0994-4. Epub 2009 Jul 24. PubMed 19629605 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2014 to primary completion in Oct 2016, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2015
First posted
Jul 16, 2015
StartActual
Jun 16, 2014
Primary completionActual
Oct 21, 2016
CompletionActual
Oct 21, 2016
Last update
Mar 28, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02499523
Lead sponsor
Materialise
Responsible party
Sponsor
First posted
Jul 16, 2015
Start date
Jun 16, 2014
Primary completion
Oct 21, 2016
Completion
Oct 21, 2016
Last update
Mar 28, 2017

Study contacts

Pieter Dolhain
principal investigator · AZ Monica

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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