Lower Thighbone and Knee Joint ReplacementPhase 1NCT00591812
Evaluation of the Compress Distal Femoral Replacement System
A Phase 1 study testing ComPreSs Distal Femoral Replacement System. in people with Lower Thighbone and Knee Joint Replacement, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Patients in this study require a replacement of a lower thighbone and knee joint. A new device, called the ComPreSs, will be used in this study to replace the lower thighbone. This new device has not yet been approved by the Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Lower Thighbone and Knee Joint Replacement
- What is being tested?
- ComPreSs Distal Femoral Replacement System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to May 2009
- Phase
- Phase 1
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with bone tumors of the distal femur requiring primary bone resection of up to 30 cm with the resection at or below the lesser trochanter.
- Patients with prior orthopaedic oncologic conditions requiring revisions of distal femoral replacement devices with a total replacement height of 30 cm or less and the resection level is at or below the lesser trochanter.
- Patients who have a cortical bone thickness of 2.5 mm or larger in the region where the ComPreSs device would be implanted.
- Patients diagnosed with a bone tumor classified as Stage 1A, IB, IIA, IIB, or III by Enneking's classification system. (See section 12.0, #7)
Who cannot join
- Patients with active infection.
- Patients who are unable to return for follow-up examinations.
- Patients who have cortical bone thickness less than 2.5 mm in the region where the ComPreSs device would be implanted.
- Patients who are unwilling or incapable of following postoperative care instructions.
- Patients requiring bilateral knee implants.
- Patients with evidence of vascular insufficiency (arterial and/or venous).
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- Patients having Parkinson's disease, severe muscular atrophy, neuromuscular disease in the affected limb.
- Patients with prior irradiated bone.
- Patients with metastatic cancer including carcinoma, melanoma, myeloma, lymphoma, leukemia.
- Patients with pathologic soft tissue or skeletal conditions that would prevent secure fixation of the device in the bone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Patients in this study require a replacement of a lower thighbone and knee joint. A new device, called the ComPreSs, will be used in this study to replace the lower thighbone. This new device has not yet been approved by the Food and Drug Administration (FDA). There is not enough data to assure that it is as good as other devices currently available. Taking part in this study will help provide data to the FDA. Other devices used to replace large pieces of bone and joints in the leg can result in damage to the bone over time. The bone damage can cause the device to come loose from the bone. This is a bad problem, and causes pain, and often more surgery is needed. This new device connects to the bone in a different way to prevent some of the problems seen with other devices. The new device protects the bone, and may help the replacement last longer. So far, the device has been used in over 50 patients on a selective basis.
- Being tested
- ComPreSs Distal Femoral Replacement System.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComPreSs Distal Femoral Replacement System.Device
ComPreSs system of intramedullary fixation along with the Finn Knee system
| Study group | Role | What they receive |
|---|---|---|
| 1 - ComPreSs system | Experimental | Not described Receives: Device: ComPreSs Distal Femoral Replacement System. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startApr 2000
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Thighbone and Knee Joint ReplacementStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- John Healey, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591812
- Sponsor's protocol ID
- 00-038
- Status last verified
- Jun 2023
- First submitted
- 26 Dec 2007
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Compress Distal Femoral Replacement System
- ClinicalTrials.gov ID
- NCT00591812
- Acronym / sponsor ID
- 00-038
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Apr 2000
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Jan 2008 (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.
Patients in this study require a replacement of a lower thighbone and knee joint. A new device, called the ComPreSs, will be used in this study to replace the lower thighbone. This new device has not yet been approved by the Food and Drug Administration (FDA). There is not enough data to assure that it is as good as other devices currently available. Taking part in this study will help provide data to the FDA. Other devices used to replace large pieces of bone and joints in the leg can result in damage to the bone over time. The bone damage can cause the device to come loose from the bone. This is a bad problem, and causes pain, and often more surgery is needed. This new device connects to the bone in a different way to prevent some of the problems seen with other devices. The new device protects the bone, and may help the replacement last longer. So far, the device has been used in over 50 patients on a selective basis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 - ComPreSs system | Experimental | Device: ComPreSs Distal Femoral Replacement System. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with bone tumors of the distal femur requiring primary bone resection of up to 30 cm with the resection at or below the lesser trochanter.
- Patients with prior orthopaedic oncologic conditions requiring revisions of distal femoral replacement devices with a total replacement height of 30 cm or less and the resection level is at or below the lesser trochanter.
- Patients who have a cortical bone thickness of 2.5 mm or larger in the region where the ComPreSs device would be implanted.
- Patients diagnosed with a bone tumor classified as Stage 1A, IB, IIA, IIB, or III by Enneking's classification system. (See section 12.0, #7)
Key exclusion criteria (10 listed)
- Patients with active infection.
- Patients who are unable to return for follow-up examinations.
- Patients who have cortical bone thickness less than 2.5 mm in the region where the ComPreSs device would be implanted.
- Patients who are unwilling or incapable of following postoperative care instructions.
- Patients requiring bilateral knee implants.
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 |
|---|---|---|
| ComPreSs Distal Femoral Replacement System.ComPreSs system of intramedullary fixation along with the Finn Knee system | Device | 1 - ComPreSs system |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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.
John Healey, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ComPreSs Distal Femoral Replacement System. in people with Lower Thighbone and Knee Joint Replacement, run by Memorial Sloan Kettering Cancer Center at 1 site 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 10 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: finished, as of the sponsor's last update on 22 Jun 2023. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Jun 2023.