Periacetabular TumorPhase 2NCT05593146
A Randomized Controlled Study Evaluating Modified Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction
A Phase 2 study testing modified anteversion angle placement(( α-15°)±10°) and conventional anteversion angle placement ( α±10°) in people with Periacetabular Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Periacetabular Tumor
- What is being tested?
- modified anteversion angle placement(( α-15°)±10°) and conventional anteversion angle placement ( α±10°)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2023to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age above 16 years old, gender is not limited.
- Tumor involving periacetabulum, femoral head, femoral neck or proximal femur
- Patients require 3D-printed hemipelvic endoprosthetic reconstruction following periacetabular tumor resection
- The subject has an estimated survival period of at least one year or more.
- The subjects with informed consent
Who cannot join
- The patient used to conduct surgery on his/her hip joint
- The patient's current surgery aimed for hip revision for implant failure or infection
- The patient didn't conduct hip endoprosthetic reconstruction
- Patients with congenital defects in the gluteal muscle group, neurological function or pelvic tilt deformity severe enough to affect functional activity
- Patients cannot self-assess postoperative function after surgery
- According to the judgment of the investigator/supervisor, there may be difficulties in completing postoperative follow-up
- Subjects have participated in similar research projects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ningbo No.6 Hospital
Ningbo, Zhejiang, 311200
About this study
Official title: A Multi-center, Double-blinded, Randomized Controlled Study Comparing Modified Cup Anteversion vs Conventional Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction
The purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.
The hypothesis is that patients with placement of the modified (( α-15°)±10°) anteversion angle of the acetabular component will have decreased risk of dislocation 1 year after surgery compared to patients with conventional anteversion angle ( α±10°) placement.
PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted
Read the detailed description
Hip dislocation is a common complication in patients who undergo reconstruction surgery after periacetabular tumor resection and most of these cases are anterior dislocations. Studies suggest that this type of dislocation may be closely related to the position and anteversion angle of the acetabular component. Therefore, properly reducing the anteversion angle of the acetabular cup during reconstruction might effectively prevent possible collisions between the cup and the femoral component, thereby reducing the potential risk of dislocation. Based on this theory, we aim to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.
PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected size. A standard error within 10° is accepted.
- Conditions
- Periacetabular Tumor
- Being tested
- modified anteversion angle placement(( α-15°)±10°), conventional anteversion angle placement ( α±10°)
- Keywords
- dislocation, endoprosthetic reconstruction, anteversion angle, pelvis
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified anteversion angle placement(( α-15°)±10°)Behavioural
Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis pre- designed anteversion angle is assembled for reconstruction after tumor resection.
Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does.
conventional anteversion angle placement ( α±10°)Behavioural
Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis with predesigned anteversion angle is assembled for reconstruction following tumor resection.
Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does.
| Study group | Role | What they receive |
|---|---|---|
| modified anteversion angle placement (( α-15°)±10°) of the acetabular component | Experimental | α refers to the anatomical preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted Receives: Behavioral: modified anteversion angle placement(( α-15°)±10°) |
| conventional anteversion angle placement ( α±10°) of the acetabular component | Placebo comparator | α refers to the anatomical preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted Receives: Behavioral: conventional anteversion angle placement ( α±10°) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoint for patient participation will dislocate
postoperative hip dislocation
Measured: followed for 1 years postoperatively for study end points
Secondary outcomes (3)
MSTS score
The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research
Measured: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints
TESS score
Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours
Measured: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints
Henderson's failure mode
1: soft tissue failure; 2: aseptic loosening; 3: structural failure; 4: periprosthetic infection; 5: tumor progression
Measured: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start13 Apr 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periacetabular TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593146
- Sponsor's protocol ID
- 2022_QH1020
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blinded, Randomized Controlled Study Comparing Modified Cup Anteversion vs Conventional Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction
- ClinicalTrials.gov ID
- NCT05593146
- Acronym / sponsor ID
- 2022_QH1020
- Conditions
- Periacetabular Tumor
- Keywords
- dislocation, endoprosthetic reconstruction, anteversion angle, pelvis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 25 Oct 2022 (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 purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.
The hypothesis is that patients with placement of the modified (( α-15°)±10°) anteversion angle of the acetabular component will have decreased risk of dislocation 1 year after surgery compared to patients with conventional anteversion angle ( α±10°) placement.
PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted
Detailed description
Hip dislocation is a common complication in patients who undergo reconstruction surgery after periacetabular tumor resection and most of these cases are anterior dislocations. Studies suggest that this type of dislocation may be closely related to the position and anteversion angle of the acetabular component. Therefore, properly reducing the anteversion angle of the acetabular cup during reconstruction might effectively prevent possible collisions between the cup and the femoral component, thereby reducing the potential risk of dislocation. Based on this theory, we aim to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.
PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected size. A standard error within 10° is accepted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified anteversion angle placement (( α-15°)±10°) of the acetabular component | Experimental | Behavioral: modified anteversion angle placement(( α-15°)±10°)α refers to the anatomical preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted |
| conventional anteversion angle placement ( α±10°) of the acetabular component | Placebo comparator | Behavioral: conventional anteversion angle placement ( α±10°)α refers to the anatomical preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 16 years old, gender is not limited.
- Tumor involving periacetabulum, femoral head, femoral neck or proximal femur
- Patients require 3D-printed hemipelvic endoprosthetic reconstruction following periacetabular tumor resection
- The subject has an estimated survival period of at least one year or more.
- The subjects with informed consent
Key exclusion criteria (7 listed)
- The patient used to conduct surgery on his/her hip joint
- The patient's current surgery aimed for hip revision for implant failure or infection
- The patient didn't conduct hip endoprosthetic reconstruction
- Patients with congenital defects in the gluteal muscle group, neurological function or pelvic tilt deformity severe enough to affect functional activity
- Patients cannot self-assess postoperative function after surgery
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 |
|---|---|---|
| modified anteversion angle placement(( α-15°)±10°)Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis pre- designed anteversion angle is assembled for reconstruction after tumor resection. Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does. | Behavioural | modified anteversion angle placement (( α-15°)±10°) of the acetabular component |
| conventional anteversion angle placement ( α±10°)Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis with predesigned anteversion angle is assembled for reconstruction following tumor resection. Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does. | Behavioural | conventional anteversion angle placement ( α±10°) of the acetabular component |
Primary outcome
The endpoint for patient participation will dislocate
Time frame: followed for 1 years postoperatively for study end points
postoperative hip dislocation
3 secondary outcomes
MSTS score
Time frame: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints
TESS score
Time frame: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints
Henderson's failure mode
Time frame: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing modified anteversion angle placement(( α-15°)±10°) and conventional anteversion angle placement ( α±10°) in people with Periacetabular Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 6 Mar 2024. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Qu, MD (13666615399, email@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endpoint for patient participation will dislocate (time frame: followed for 1 years postoperatively for study end points). 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 6 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.