Osteoarthritis, HipNCT02499523
Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
A study testing THR with conventional technique and THR with Acetabular Cup Orientation Guides (ACOG) in people with Osteoarthritis, Hip, run by Materialise at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- THR with conventional technique and THR with Acetabular Cup Orientation Guides (ACOG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Jun 2014to 21 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is selected to undergo a primary THR
- Informed consent
Who cannot join
- 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 BMI > 35
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- THR with conventional technique, THR with Acetabular Cup Orientation Guides (ACOG)
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THR with conventional techniqueProcedure or surgery
THR with conventional technique.
THR with Acetabular Cup Orientation Guides (ACOG)Procedure or surgery
Also called ACOG, Materialise
THR with the ACOG System.
| Study group | Role | What they receive |
|---|---|---|
| THR with conventional technique | Active comparator | Use of conventional technique in THR Receives: Procedure: THR with conventional technique |
| THR with ACOG | Experimental | THR with Acetabular Cup Orientation Guides (ACOG) Receives: Procedure: THR with Acetabular Cup Orientation Guides (ACOG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular cup positioning
Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.
Measured: 2 Months post-operatively
Secondary outcomes (2)
Surgery time
Measured: 1 day
Acetabular cup size
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start16 Jun 2014
- Primary completion21 Oct 2016
- Study completion21 Oct 2016
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materialise
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pieter Dolhain, Principal investigator, AZ Monica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499523
- Sponsor's protocol ID
- SMAT003
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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 19248055Hananouchi 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Controlled Monocentric Study on Acetabulum Patient-specific Pin Drilling Guides
- ClinicalTrials.gov ID
- NCT02499523
- Acronym / sponsor ID
- SMAT003
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MaterialiseIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 21 Oct 2016 (actual)
- Study completion
- 21 Oct 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THR with conventional technique | Active comparator | Procedure: THR with conventional techniqueUse of conventional technique in THR |
| THR with ACOG | Experimental | Procedure: THR with Acetabular Cup Orientation Guides (ACOG)THR with Acetabular Cup Orientation Guides (ACOG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is selected to undergo a primary THR
- Informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THR with conventional techniqueTHR with conventional technique. | Procedure or surgery | THR with conventional technique |
| THR with Acetabular Cup Orientation Guides (ACOG)Also: ACOG, MaterialiseTHR with the ACOG System. | Procedure or surgery | THR with ACOG |
Primary outcome
Acetabular cup positioning
Time frame: 2 Months post-operatively
Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups.
2 secondary outcomes
Surgery time
Time frame: 1 day
Acetabular cup size
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Results publication: PubMed 19248055Hananouchi 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.
- Results publication: PubMed 19629605Hananouchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Dolhain principal investigator
AZ Monica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THR with conventional technique and THR with Acetabular Cup Orientation Guides (ACOG) in people with Osteoarthritis, Hip, run by Materialise at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular cup positioning (time frame: 2 Months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02499523, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.