Osteoarthritis, KneePhase 3NCT03060382
The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
A Phase 3 study testing balanced buttress absorbable spacer and total knee arthroplasty in people with Osteoarthritis, Knee, run by Hebei Medical University Third Hospital at 2 sites in China.
Trial summary
The investigators randomly divided the knee osteoarthritis patients met the inclusive criteria into two groups (study group and control group). Placement of balanced buttress absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two groups were compared in this study. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- balanced buttress absorbable spacer and total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2017to Jan 2019
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-80 years old
- Medial stenosis of the knee
- Varus deformity less than 20 degrees
Who cannot join
- Lateral stenosis of the knee
- Hepatic renal dysfunction
- Refuse to participate the study
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 050051
Yingze Zhang, M.D, +8613313012888, yzzhangdr@126.com
- Recruiting
Zhiyong Hou
Shijiazhuang, Hebei, 050051
Zhiyong Hou, M.D, +8618533112800, houzhiyong1234@126.com
Ruipeng Zhang, M.D
About this study
The investigators randomly divided the knee osteoarthritis patients met the inclusive criteria into two groups (study group and control group). Placement of balanced buttress absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two groups were compared in this study.
Read the detailed description
Knee osteoarthritis, caused by non-uniform settlement of medial and lateral tibial plateau, was not uncommon in clinic. Medial stenosis was the most type of the disease. The symptoms included knee pain during walking and varus deformity of lower limbs. Total knee arthroplasty and tibial osteotomy were two common conventional treatment of the knee osteoarthritis, which were not minimally invasive and bring great financial burden to patients' family. The investigators planned to recruit 150 patients of knee osteoarthritis into this study, which were randomly divided into two groups (study group and control group). For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line. However, total knee arthroplasty was conducted for the patients of control group. The patients were followed up and the clinical outcomes were compared in this study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- balanced buttress absorbable spacer, total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanced buttress absorbable spacerDevice
For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line.
total knee arthroplastyBiological
Total knee arthroplasty was conducted for the patients of control group
| Study group | Role | What they receive |
|---|---|---|
| balanced buttress absorbable spacer | Experimental | For the patients of study group, a balanced buttress absorbable spacer was placed into tibia. Receives: Device: balanced buttress absorbable spacer |
| total knee arthroplasty | Placebo comparator | For the patients of control group, total knee arthroplasty was conducted. Receives: Biological: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome
walking distance the patients could bear
Measured: 12 months
Secondary outcomes (1)
complication
vascular nerve bundle injury
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingze Zhang, M.D, Study chair, Third Hospital of Hebei Medical University Department of Orthopaedic SurgeryZhiyong Hou, M.D, Study director, Third Hospital of Hebei Medical University Department of Orthopaedic SurgeryRuipeng Zhang, M.D, Principal investigator, Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060382
- Sponsor's protocol ID
- DP2017
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Knee Osteoarthritis With Balanced Buttress Absorbable Spacer
- ClinicalTrials.gov ID
- NCT03060382
- Acronym / sponsor ID
- DP2017
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 23 Feb 2017 (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.
The investigators randomly divided the knee osteoarthritis patients met the inclusive criteria into two groups (study group and control group). Placement of balanced buttress absorbable spacer and total knee arthroplasty were conducted. The clinical outcome of two groups were compared in this study.
Detailed description
Knee osteoarthritis, caused by non-uniform settlement of medial and lateral tibial plateau, was not uncommon in clinic. Medial stenosis was the most type of the disease. The symptoms included knee pain during walking and varus deformity of lower limbs. Total knee arthroplasty and tibial osteotomy were two common conventional treatment of the knee osteoarthritis, which were not minimally invasive and bring great financial burden to patients' family. The investigators planned to recruit 150 patients of knee osteoarthritis into this study, which were randomly divided into two groups (study group and control group). For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line. However, total knee arthroplasty was conducted for the patients of control group. The patients were followed up and the clinical outcomes were compared in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| balanced buttress absorbable spacer | Experimental | Device: balanced buttress absorbable spacerFor the patients of study group, a balanced buttress absorbable spacer was placed into tibia. |
| total knee arthroplasty | Placebo comparator | Biological: total knee arthroplastyFor the patients of control group, total knee arthroplasty was conducted. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-80 years old
- Medial stenosis of the knee
- Varus deformity less than 20 degrees
Key exclusion criteria (3 listed)
- Lateral stenosis of the knee
- Hepatic renal dysfunction
- Refuse to participate the study
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 |
|---|---|---|
| balanced buttress absorbable spacerFor the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line. | Device | balanced buttress absorbable spacer |
| total knee arthroplastyTotal knee arthroplasty was conducted for the patients of control group | Biological | total knee arthroplasty |
Primary outcome
functional outcome
Time frame: 12 months
walking distance the patients could bear
1 secondary outcome
complication
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: Yes
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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.
Yingze Zhang, M.D study chair
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Zhiyong Hou, M.D study director
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Ruipeng Zhang, M.D principal investigator
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing balanced buttress absorbable spacer and total knee arthroplasty in people with Osteoarthritis, Knee, run by Hebei Medical University Third Hospital at 2 sites in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingze Zhang, M.D (+8613313012888, yzzhangdr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome (time frame: 12 months). 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 23 Jun 2017.