Postoperative PainNCT04592939
Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
A study testing immediate weight bearing after surgery and 6 weeks of toe-touch weight bearing after surgery in people with Postoperative Pain and Hip Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Hip Arthroplasty
- What is being tested?
- immediate weight bearing after surgery and 6 weeks of toe-touch weight bearing after surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 31 Oct 2021
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- femoral revision patients with the use of a modern titanium, fluted, tapered stem.
Who cannot join
- include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated
- Conditions
- Postoperative Pain, Hip Arthroplasty
- Being tested
- immediate weight bearing after surgery, 6 weeks of toe-touch weight bearing after surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate weight bearing after surgeryProcedure or surgery
immediate weight bearing
6 weeks of toe-touch weight bearing after surgeryProcedure or surgery
6 weeks of toe-touch weight bearing
| Study group | Role | What they receive |
|---|---|---|
| Group 1: immediate weight bearing | Other | Not described Receives: Procedure: immediate weight bearing after surgery |
| Group 2: 6 week toe touch weight bearing | Other | Not described Receives: Procedure: 6 weeks of toe-touch weight bearing after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to function
time to return to baseline ambulatory status
Measured: 1 year
Postoperative Complications
radiographic measurements of subsidence of the stem
Measured: 1 year
Implant survival
re-revision rates within one year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Oct 2020 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592939
- Sponsor's protocol ID
- PMC20D.220
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 22 Oct 2020
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems
- ClinicalTrials.gov ID
- NCT04592939
- Acronym / sponsor ID
- PMC20D.220
- Conditions
- Postoperative Pain, Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 19 Oct 2020 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 19 Oct 2020 (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, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: immediate weight bearing | Other | Procedure: immediate weight bearing after surgery |
| Group 2: 6 week toe touch weight bearing | Other | Procedure: 6 weeks of toe-touch weight bearing after surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- femoral revision patients with the use of a modern titanium, fluted, tapered stem.
Key exclusion criteria (1 listed)
- include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing
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 |
|---|---|---|
| immediate weight bearing after surgeryimmediate weight bearing | Procedure or surgery | Group 1: immediate weight bearing |
| 6 weeks of toe-touch weight bearing after surgery6 weeks of toe-touch weight bearing | Procedure or surgery | Group 2: 6 week toe touch weight bearing |
Primary outcome
Return to function
Time frame: 1 year
time to return to baseline ambulatory status
Postoperative Complications
Time frame: 1 year
radiographic measurements of subsidence of the stem
Implant survival
Time frame: 1 year
re-revision rates within one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate weight bearing after surgery and 6 weeks of toe-touch weight bearing after surgery in people with Postoperative Pain and Hip Arthroplasty, run by Rothman Institute Orthopaedics 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 1 inclusion and 1 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 22 Oct 2020. 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.
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?
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?
Return to function (time frame: 1 year). The study lists 3 primary outcomes in all. 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 22 Oct 2020.