Clinical Condition Included in the Approved Indications For Use for the Conformis Hip SystemNCT03738462
A Study to Evaluate the Conformis Hip System
An observational study of Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System, run by Restor3D at 6 sites in United States.
Trial summary
This is a prospective multicenter study. Subjects will be implanted with a Conformis Hip System. If the surgeon intraoperatively decides to use the Cordera femoral stem, these patients will also be enrolled in the study and tracked as a subset of the Conformis Hip System patient population.The study sites will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
- What is being tested?
- Conformis Hip System
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Nov 2018to 6 Jun 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera Hip System
Who may be able to join
- Clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera Hip System
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a THR procedure
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- > 18 years of age
Who cannot join
- Simultaneous bilateral procedure required
- BMI > 40
- Poorly controlled diabetes (defined as HbA1c>7 or Investigator discretion)
- Crowe classification of hip dysplasia, grades 2, 3, or 4
- Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
- Other lower extremity surgery planned within 1 year of consent to the affected limb Contralateral THR surgery within 3 months pre or post index surgery
Show all 18Show fewer
- Neuromuscular conditions which prevent patient from participating in study activities
- Active local or systemic infection which precludes THR procedure
- Immunocompromised in the opinion of the Investigator
- Medically diagnosed fibromyalgia or similar conditions that might impact the patient's ability to differentiate source of pain
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified
- Diagnosed with or receiving treatment for osteoporosis that is likely to confound results in the opinion of the Investigator
- Physical disability affecting the lumbar spine that is likely to confound results in the opinion of the Investigator
- Charcot or Paget's disease
- Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
- Participation in another clinical study which would confound results
- Allergy to any of the implant materials
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Personalized Orthopedic Research Institute
Boynton Beach, Florida, 33437
Orthopaedic Institute of Henderson
Henderson, Nevada, 89052
Scott Orthopedic Center
Huntington, West Virginia, 25702
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37203
Denver Hip and Knee
Parker, Colorado, 80134
The Orthopedic Specialty Center of Northern California
Roseville, California, 95678
About this study
Official title: A Prospective, Multicenter Study to Evaluate the Conformis Hip System
This is a prospective multicenter study. Subjects will be implanted with a Conformis Hip System. If the surgeon intraoperatively decides to use the Cordera femoral stem, these patients will also be enrolled in the study and tracked as a subset of the Conformis Hip System patient population.The study sites will be located in the United States. The study subjects will be followed for 10 years post implantation.
- Conditions
- Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
- Being tested
- Conformis Hip System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conformis Hip SystemDevice
Also called Cordera Hip System
The Conformis Hip System is an FDA cleared, uncemented, primary total hip replacement device composed of femoral and acetabular components. The system incorporates the use of a pre-operative CT scan to design patient-specific implants and instruments. Using patient imaging (CT scan), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. In addition, each Conformis Hip System device is shipped with an additional (optional) femoral stem (Cordera Femoral Stem).
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Score 0-100 (successful result = post operative increase in Harris Hip Score of > 20 points + radiographically stable implant + no additional femoral reconstruction; < 70 = poor, 70-79 - fair, 80-89 = good, and 90-100 = excellent)
Measured: 2 Years
Secondary outcomes (8)
Revision rates post-implantation
Measured: 10 Years
The Hip Injury and Osteoarthritis Outcome Score (HOOS)
Score 0-100 for each of 5 subscales (symptoms, stiffness, pain, function, and quality of life)
Measured: 10 Years
Incidence of major procedure-related and device-related complications including infection rate
Measured: 10 Years
Post-operative leg length and implant placement in comparison to preoperative condition
Measured: Peri-operative
Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized)
Measured: Peri-operative
Length of procedure
Measured: Peri-operative
Length of hospital stay
Measured: Peri-operative
Blood management (transfusions)
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start26 Nov 2018
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Why it stopped: Decision of investigational team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Condition Included in the Approved Indications For Use for the Conformis Hip SystemStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738462
- Sponsor's protocol ID
- 18-001
- Status last verified
- Oct 2023
- First submitted
- 29 Oct 2018
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Conformis Hip System
- ClinicalTrials.gov ID
- NCT03738462
- Acronym / sponsor ID
- 18-001
- Conditions
- Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of investigational team
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- 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.
This is a prospective multicenter study. Subjects will be implanted with a Conformis Hip System. If the surgeon intraoperatively decides to use the Cordera femoral stem, these patients will also be enrolled in the study and tracked as a subset of the Conformis Hip System patient population.The study sites will be located in the United States. The study subjects will be followed for 10 years post implantation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera Hip System
Key inclusion criteria (4 listed)
- Clinical condition included in the approved Indications For Use for the Conformis Hip System and the Cordera Hip System
- Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a THR procedure
- Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
- > 18 years of age
Key exclusion criteria (18 listed)
- Simultaneous bilateral procedure required
- BMI > 40
- Poorly controlled diabetes (defined as HbA1c>7 or Investigator discretion)
- Crowe classification of hip dysplasia, grades 2, 3, or 4
- Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
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 |
|---|---|---|
| Conformis Hip SystemAlso: Cordera Hip SystemThe Conformis Hip System is an FDA cleared, uncemented, primary total hip replacement device composed of femoral and acetabular components. The system incorporates the use of a pre-operative CT scan to design patient-specific implants and instruments. Using patient imaging (CT scan), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. In addition, each Conformis Hip System device is shipped with an additional (optional) femoral stem (Cordera Femoral Stem). | Device | – |
Primary outcome
Harris Hip Score
Time frame: 2 Years
Score 0-100 (successful result = post operative increase in Harris Hip Score of > 20 points + radiographically stable implant + no additional femoral reconstruction; < 70 = poor, 70-79 - fair, 80-89 = good, and 90-100 = excellent)
8 secondary outcomes
Revision rates post-implantation
Time frame: 10 Years
The Hip Injury and Osteoarthritis Outcome Score (HOOS)
Time frame: 10 Years
Incidence of major procedure-related and device-related complications including infection rate
Time frame: 10 Years
Post-operative leg length and implant placement in comparison to preoperative condition
Time frame: Peri-operative
Utilization of fluoroscopy during implantation (number of times utilized; amount of times utilized)
Time frame: Peri-operative
Length of procedure
Time frame: Peri-operative
Length of hospital stay
Time frame: Peri-operative
Blood management (transfusions)
Time frame: Peri-operative
Results and safety
The study was stopped early (reason given: Decision of investigational team). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Condition Included in the Approved Indications For Use for the Conformis Hip System, run by Restor3D at 6 sites in United States.
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 4 inclusion and 18 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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: Decision of investigational team). 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?
Harris Hip Score (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2023.