Hip OsteoarthritisNCT01857505
Hip Replacement in a High Volume Community Hospital: Effect on Length of Stay and Hospital Cost
An observational study of Hip Osteoarthritis, run by Anne Arundel Health System Research Institute at 1 site in United States.
Trial summary
The investigators propose to evaluate and compare the percentage of patients who are able to be discharged in less than 3 days after undergoing total hip arthroscopy through either a direct anterior or posterior approach, utilizing the identical post operative protocol. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Hip Osteoarthritis
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 2014
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone primary uncemented hip replacement at our institution (Anne Arundel Medical Center) through either a posterior approach or direct anterior approach on a fracture table utilizing the identical post operative protocol.
Who may be able to join
- Consecutive single surgeon series of patients who have undergone primary uncemented hip replacement at our institution through either a posterior approach or direct anterior approach on a fracture table. Posterior approach patient - most recent patient prior to March, 2010, compared with consecutive recent anterior approach patients with minimum of 6 month follow-up.
- Diagnosis of osteoarthritis, inflammatory arthritis, or avascular necrosis.
- No previous surgery on affected hip.
- Age 40-90 at time of surgery
Who cannot join
- Patient not permitted to bear full weight after the procedure, per post operative instructions
- Hip replacement performed for acute fracture.
- Previous hip surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne Arundel Medical Center
Annapolis, Maryland, 21401
About this study
Official title: Introduction of the Direct Anterior Approach to Hip Replacement Into a High Volume Community Hospital: Effect on Length of Stay and Hospital Cost
The investigators propose to evaluate and compare the percentage of patients who are able to be discharged in less than 3 days after undergoing total hip arthroscopy through either a direct anterior or posterior approach, utilizing the identical post operative protocol. The investigators also propose to evaluate the costs associated with the two different approaches to hip replacement in the same group of patients. Post operative resource utilization, discharge disposition, and pain medicine requirement will also be evaluated.
Read the detailed description
The investigators hypothesize that a higher proportion of patients treated with the direct anterior approach for hip replacement will be able to leave the hospital in less than 3 days when compared with a less invasive posterior approach. Secondly, decreased length of stay associated with the procedure may reduce hospital costs.
- Conditions
- Hip Osteoarthritis
- Keywords
- Total Hip replacement, Fracture table, DePuySynthes, Direct anterior approach hip replacement, Posterior approach hip replacement
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Direct Anterior Approach hip replacement | Single surgeon series of 105 consecutive patients who underwent hip replacement via the direct anterior approach on a fracture table | |
| Posterior Approach Hip Replacement | 105 consecutive patients previously operated on by a less invasive posterior approach at the same institution. These surgeries occurred prior to March, 2010. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay
The length of stay and proportion of patients who went home in less than 3 days will be determined for each group. To evaluate and compare the percentage of patients who are able to be discharged in less than 3 days after undergoing total hip arthroscopy through either a direct anterior or posterior approach, utilizing the identical post operative protocol.
Measured: Retrospective review of hospital discharge records
Hospital cost
Hospital cost analysis will be undertaken for each group.
Measured: Retrospective review of utilization records
Secondary outcomes (2)
Post Operative Pain Medication Utilization
Analysis of post operative pain medicine requirement will be compared for the two groups.
Measured: After retrospective chart review is complete -- approximately 6 months
Utilization of inpatient physical therapy resources
Utilization of inpatient physical therapy resources and post hospital discharge disposition will be compared for the two groups.
Measured: Retrospective review -- of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Primary completionJan 2014
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Arundel Health System Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Paul King, M.D., Principal investigator, Anne Arundel Medical Center / Anne Arundel Orthopedic Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857505
- Sponsor's protocol ID
- IIS-000158
- Status last verified
- Dec 2014
- First submitted
- 10 May 2013
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes JH, Cleary R, Gillespie WJ, Pinder IM, Sher JL. Are clinical and patient assessed outcomes affected by reducing length of hospital stay for total hip arthroplasty? J Arthroplasty. 2000 Jun;15(4):448-52. doi: 10.1054/arth.2000.4346.
PubMed 10884204Vorhies JS, Wang Y, Herndon J, Maloney WJ, Huddleston JI. Readmission and length of stay after total hip arthroplasty in a national Medicare sample. J Arthroplasty. 2011 Sep;26(6 Suppl):119-23. doi: 10.1016/j.arth.2011.04.036. Epub 2011 Jul 1.
PubMed 21723700Duwelius PJ, Moller HS, Burkhart RL, Waller F, Wu Y, Grunkemeier GL. The economic impact of minimally invasive total hip arthroplasty. J Arthroplasty. 2011 Sep;26(6):883-5. doi: 10.1016/j.arth.2010.09.011. Epub 2010 Nov 3.
PubMed 21051190Matta JM, Ferguson TA. The anterior approach for hip replacement. Orthopedics. 2005 Sep;28(9):927-8. doi: 10.3928/0147-7447-20050901-11. No abstract available.
PubMed 16190055Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.
PubMed 16330993
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of the Direct Anterior Approach to Hip Replacement Into a High Volume Community Hospital: Effect on Length of Stay and Hospital Cost
- ClinicalTrials.gov ID
- NCT01857505
- Acronym / sponsor ID
- IIS-000158
- Conditions
- Hip Osteoarthritis
- Keywords
- Total Hip replacement, Fracture table, DePuySynthes, Direct anterior approach hip replacement, Posterior approach hip replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anne Arundel Health System Research InstituteUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Primary completion
- Jan 2014 (actual)
- First posted
- 20 May 2013 (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.
The investigators propose to evaluate and compare the percentage of patients who are able to be discharged in less than 3 days after undergoing total hip arthroscopy through either a direct anterior or posterior approach, utilizing the identical post operative protocol. The investigators also propose to evaluate the costs associated with the two different approaches to hip replacement in the same group of patients. Post operative resource utilization, discharge disposition, and pain medicine requirement will also be evaluated.
Detailed description
The investigators hypothesize that a higher proportion of patients treated with the direct anterior approach for hip replacement will be able to leave the hospital in less than 3 days when compared with a less invasive posterior approach. Secondly, decreased length of stay associated with the procedure may reduce hospital costs.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Anterior Approach hip replacement | – | –Single surgeon series of 105 consecutive patients who underwent hip replacement via the direct anterior approach on a fracture table |
| Posterior Approach Hip Replacement | – | –105 consecutive patients previously operated on by a less invasive posterior approach at the same institution. These surgeries occurred prior to March, 2010. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone primary uncemented hip replacement at our institution (Anne Arundel Medical Center) through either a posterior approach or direct anterior approach on a fracture table utilizing the identical post operative protocol.
Key inclusion criteria (4 listed)
- Consecutive single surgeon series of patients who have undergone primary uncemented hip replacement at our institution through either a posterior approach or direct anterior approach on a fracture table. Posterior approach patient - most recent patient prior to March, 2010, compared with consecutive recent anterior approach patients with minimum of 6 month follow-up.
- Diagnosis of osteoarthritis, inflammatory arthritis, or avascular necrosis.
- No previous surgery on affected hip.
- Age 40-90 at time of surgery
Key exclusion criteria (3 listed)
- Patient not permitted to bear full weight after the procedure, per post operative instructions
- Hip replacement performed for acute fracture.
- Previous hip surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of Hospital Stay
Time frame: Retrospective review of hospital discharge records
The length of stay and proportion of patients who went home in less than 3 days will be determined for each group. To evaluate and compare the percentage of patients who are able to be discharged in less than 3 days after undergoing total hip arthroscopy through either a direct anterior or posterior approach, utilizing the identical post operative protocol.
Hospital cost
Time frame: Retrospective review of utilization records
Hospital cost analysis will be undertaken for each group.
2 secondary outcomes
Post Operative Pain Medication Utilization
Time frame: After retrospective chart review is complete -- approximately 6 months
Utilization of inpatient physical therapy resources
Time frame: Retrospective review -- of hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 10884204Hayes JH, Cleary R, Gillespie WJ, Pinder IM, Sher JL. Are clinical and patient assessed outcomes affected by reducing length of hospital stay for total hip arthroplasty? J Arthroplasty. 2000 Jun;15(4):448-52. doi: 10.1054/arth.2000.4346.
- Background: PubMed 21723700Vorhies JS, Wang Y, Herndon J, Maloney WJ, Huddleston JI. Readmission and length of stay after total hip arthroplasty in a national Medicare sample. J Arthroplasty. 2011 Sep;26(6 Suppl):119-23. doi: 10.1016/j.arth.2011.04.036. Epub 2011 Jul 1.
- Background: PubMed 21051190Duwelius PJ, Moller HS, Burkhart RL, Waller F, Wu Y, Grunkemeier GL. The economic impact of minimally invasive total hip arthroplasty. J Arthroplasty. 2011 Sep;26(6):883-5. doi: 10.1016/j.arth.2010.09.011. Epub 2010 Nov 3.
- Background: PubMed 16190055Matta JM, Ferguson TA. The anterior approach for hip replacement. Orthopedics. 2005 Sep;28(9):927-8. doi: 10.3928/0147-7447-20050901-11. No abstract available.
- Background: PubMed 16330993Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.
Related trials for Hip Osteoarthritis
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.
Paul King, M.D. principal investigator
Anne Arundel Medical Center / Anne Arundel Orthopedic Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis, run by Anne Arundel Health System Research Institute 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 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: withdrawn, as of the sponsor's last update on 18 Dec 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Length of Hospital Stay (time frame: Retrospective review of hospital discharge records). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01857505, which also lists 5 linked publications.
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 18 Dec 2014.