Acetabular FractureGeriTabNCT03419182
RCT Determining Best Treatment for Geriatric Acetabular Fractures
A study testing Open Reduction internal Fixation and Open Reduction Internal Fixation with Total Hip Arthroscopy in people with Acetabular Fracture, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
There is debate over the best management for acetabular (hip) fractures that occur within the geriatric population. Geriatric patients, 60 years or older, are at greater risk for operative complications because they tend to have poorer bone quality, complicated fractures, and multiple health problems. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Acetabular Fracture
- What is being tested?
- Open Reduction internal Fixation and Open Reduction Internal Fixation with Total Hip Arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2011to 1 Apr 2020
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 60 years and older at the time of injury who have sustained an acetabular fracture
- Fluent in the English Language
Who cannot join
- Patients under the Age of 60 years old
- Patients who are medically contraindicated for surgery
- Patients who in the surgeon's view will be unable to comply with posterior hip precautions (to prevent dislocation) after surgery
- In patients with bilateral acetabular fractures, the most severe side will be randomized into the study while the other side will be treated but not included in the study.
- Open Injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Department of Orthopaedics
Baltimore, Maryland, 21201
About this study
Official title: Randomized Controlled Trial to Determine the Best Treatment of Acetabular Fractures in Geriatric Patients: Open Reduction Internal Fixation With or Without Primary Total Hip Arthroplasty
There is debate over the best management for acetabular (hip) fractures that occur within the geriatric population. Geriatric patients, 60 years or older, are at greater risk for operative complications because they tend to have poorer bone quality, complicated fractures, and multiple health problems. Physicians currently have no guidelines as to the best surgical management for these particular fractures, because there is little data on the long-term outcomes of these injuries. The use of internal fixation (a nail or plate) is a standard method for repairing these injuries, however when the injuries are complicated it is predicted to have a poorer outcome than performing internal fixation along with total hip arthroplasty (joint reconstruction). Given the significant problems that result from hip fractures in this population, our study is designed to determine the best method for treatment of acetabular fractures and to clarify the criteria for treatment with guidelines assisting the physician in selecting the appropriate treatment.
Read the detailed description
This is a pilot randomized controlled study conducted at Shock Trauma and University of Maryland Medical Center of patients 60 years and older who have sustained an acetabular fracture. Based on the patient's fracture pattern, dome impaction, posterior wall component and femoral head fracture, the patients will be randomized to their treatment arm. One treatment arm will consist of patients who are treated with ORIF alone. The other treatment will undergo ORIF as well as concomitant total hip arthroplasty in the same surgery.
Furthermore the functional status evaluation of each patient will be standardized using the WOMAC (Western Ontario McMaster Universities OA index), a lower extremity specific outcome score that has been validated for use in patients of similar age to our cohort study in osteoarthritis or after total hip arthroplasty; and the SF-36 (Short Form-36) which is a validated general health outcome measure that calculates mental and physical subcomponent scores. Patients will also be assessed using the Harris Hip Score, which has been used for patients with post-traumatic arthritis undergoing conversion to total hip arthroplasty.
All patients will be followed as standard of care for their follow up visits at 6 month and 1 year. As the patient population at Shock Trauma and University of Maryland Medical Center are all treated by the same orthopaedic group, one dedicated investigator will follow their outcomes. To minimize the risk of bias, I, the individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm. As the patient will be giving consent for their treatment, they cannot be blinded. Also, the surgeons (and the research coordinator) will know which group the patient is in, but the investigator collecting the data will not.
- Conditions
- Acetabular Fracture
- Being tested
- Open Reduction internal Fixation, Open Reduction Internal Fixation with Total Hip Arthroscopy
- Keywords
- Geriatric, Acetabular, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction internal FixationProcedure or surgery
A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.
Open Reduction Internal Fixation with Total Hip ArthroscopyProcedure or surgery
A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture, and replaces the cartilage and bone of the greater trochanter with prosthetic components.
| Study group | Role | What they receive |
|---|---|---|
| RCT - ORIF | Active comparator | A patient in this study arm consents to randomization and receives RCT - ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation. Receives: Procedure: Open Reduction internal Fixation |
| RCT - (THA) + ORIF | Active comparator | A patient in this study arm consents to randomization and receives RCT - (THA) + ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty. Receives: Procedure: Open Reduction Internal Fixation with Total Hip Arthroscopy |
| OBS - ORIF | No intervention | A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation. |
| OBS (THA) + ORIF | No intervention | A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure for this study is the proportion of complications in the first 12 months following surgery
Researchers will assess treatment success using a two-group comparison of proportion of complications between the treatment groups during the first 12 months following treatment.
Complications will be identified by radiographic and clinical evaluation during standard follow-up appointments with the treating surgeon. Complications include postoperative infections, non-union, mal-union, development of heterotopic bone, development of osteoarthritis, osteolysis, hardware failure, hip dislocations, surgical revisions, and any other condition related to surgical treatment of the study injury.
Measured: 1 year
Secondary outcomes (2)
A secondary outcome for this study is to evaluate patient reported outcomes using the WOMAC Questionnaire.
All enrolled patients complete WOMAC questionnaire 6 and 12 months after surgical treatment. Patient reported outcomes are based on scores on the WOMAC questionnaire. Using a mean of 50 and a standard deviation of 10, this study will have 80% power to detect a 10% change in the patient satisfaction questionnaire.
Measured: 6 months and 12 months
A secondary outcome for this study is to evaluate patient reported outcomes using the SF36 Questionnaire.
All enrolled patients complete SF36 questionnaire 6 and 12 months after surgical treatment. Patient reported outcomes are based on scores on the SF36 questionnaire. Using a mean of 50 and a standard deviation of 10, this study will have 80% power to detect a 10% change in the patient satisfaction questionnaire.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start13 Apr 2011
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized t wo treatment groups : 1. Open reduction internal fixation (ORIF) 2. Acute primary total hip athroplasty (THA) +ORIF. These are both two standard accepted treatments for this injury. Participants who do not consent to being randomized will be asked if they would consent to participating in an observational arm. In this case, type of surgery would be planned and chosen by clinical decision making from the surgeon and patient. As these procedures are both standard of care, partipants could end up in either group as well. All follow up will be the same.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Manson, University of Maryland, Baltimore
- Investigators
- Theodore Manson, MD, Principal investigator, Associate Professor of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419182
- Sponsor's protocol ID
- HP-00047655
- Acronym
- GeriTab
- Status last verified
- Feb 2022
- First submitted
- 22 Sep 2017
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anglen JO, Burd TA, Hendricks KJ, Harrison P. The "Gull Sign": a harbinger of failure for internal fixation of geriatric acetabular fractures. J Orthop Trauma. 2003 Oct;17(9):625-34. doi: 10.1097/00005131-200310000-00005.
PubMed 14574190Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch EH, Swiontkowski M, Sanders D, Walter SD. Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008 Dec;90(12):2567-78. doi: 10.2106/JBJS.G.01694.
PubMed 19047701Boraiah S, Ragsdale M, Achor T, Zelicof S, Asprinio DE. Open reduction internal fixation and primary total hip arthroplasty of selected acetabular fractures. J Orthop Trauma. 2009 Apr;23(4):243-8. doi: 10.1097/BOT.0b013e3181923fb8.
PubMed 19318866Buckley R, Tough S, McCormack R, Pate G, Leighton R, Petrie D, Galpin R. Operative compared with nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial. J Bone Joint Surg Am. 2002 Oct;84(10):1733-44. doi: 10.2106/00004623-200210000-00001.
PubMed 12377902Cornell CN. Management of acetabular fractures in the elderly patient. HSS J. 2005 Sep;1(1):25-30. doi: 10.1007/s11420-005-0101-7.
PubMed 18751805Helfet DL, Borrelli J Jr, DiPasquale T, Sanders R. Stabilization of acetabular fractures in elderly patients. J Bone Joint Surg Am. 1992 Jun;74(5):753-65.
PubMed 1624491Herscovici D Jr, Lindvall E, Bolhofner B, Scaduto JM. The combined hip procedure: open reduction internal fixation combined with total hip arthroplasty for the management of acetabular fractures in the elderly. J Orthop Trauma. 2010 May;24(5):291-6. doi: 10.1097/BOT.0b013e3181b1d22a.
PubMed 20418734Jimenez ML, Tile M, Schenk RS. Total hip replacement after acetabular fracture. Orthop Clin North Am. 1997 Jul;28(3):435-46. doi: 10.1016/s0030-5898(05)70300-x.
PubMed 9208835Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.
PubMed 18784099Mears DC, Velyvis JH. Acute total hip arthroplasty for selected displaced acetabular fractures: two to twelve-year results. J Bone Joint Surg Am. 2002 Jan;84(1):1-9. doi: 10.2106/00004623-200201000-00001.
PubMed 11792772Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.
PubMed 8934477Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
PubMed 12110735Mouhsine E, Garofalo R, Borens O, Fischer JF, Crevoisier X, Pelet S, Blanc CH, Leyvraz PF. Acute total hip arthroplasty for acetabular fractures in the elderly: 11 patients followed for 2 years. Acta Orthop Scand. 2002 Dec;73(6):615-8. doi: 10.1080/000164702321039552.
PubMed 12553506Osgood GM, Manson TT, O'Toole RV, Turen CH. Combined pelvic ring disruption and acetabular fracture: associated injury patterns in 40 patients. J Orthop Trauma. 2013 May;27(5):243-7. doi: 10.1097/BOT.0b013e31826c2751.
PubMed 22874118O'Toole RV, Castillo RC, Pollak AN, MacKenzie EJ, Bosse MJ; LEAP Study Group. Determinants of patient satisfaction after severe lower-extremity injuries. J Bone Joint Surg Am. 2008 Jun;90(6):1206-11. doi: 10.2106/JBJS.G.00492.
PubMed 18519312
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Determine the Best Treatment of Acetabular Fractures in Geriatric Patients: Open Reduction Internal Fixation With or Without Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03419182
- Acronym / sponsor ID
- GeriTab / HP-00047655
- Conditions
- Acetabular Fracture
- Keywords
- Geriatric, Acetabular, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 13 Apr 2011 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 1 Feb 2018 (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.
There is debate over the best management for acetabular (hip) fractures that occur within the geriatric population. Geriatric patients, 60 years or older, are at greater risk for operative complications because they tend to have poorer bone quality, complicated fractures, and multiple health problems. Physicians currently have no guidelines as to the best surgical management for these particular fractures, because there is little data on the long-term outcomes of these injuries. The use of internal fixation (a nail or plate) is a standard method for repairing these injuries, however when the injuries are complicated it is predicted to have a poorer outcome than performing internal fixation along with total hip arthroplasty (joint reconstruction). Given the significant problems that result from hip fractures in this population, our study is designed to determine the best method for treatment of acetabular fractures and to clarify the criteria for treatment with guidelines assisting the physician in selecting the appropriate treatment.
Detailed description
This is a pilot randomized controlled study conducted at Shock Trauma and University of Maryland Medical Center of patients 60 years and older who have sustained an acetabular fracture. Based on the patient's fracture pattern, dome impaction, posterior wall component and femoral head fracture, the patients will be randomized to their treatment arm. One treatment arm will consist of patients who are treated with ORIF alone. The other treatment will undergo ORIF as well as concomitant total hip arthroplasty in the same surgery.
Furthermore the functional status evaluation of each patient will be standardized using the WOMAC (Western Ontario McMaster Universities OA index), a lower extremity specific outcome score that has been validated for use in patients of similar age to our cohort study in osteoarthritis or after total hip arthroplasty; and the SF-36 (Short Form-36) which is a validated general health outcome measure that calculates mental and physical subcomponent scores. Patients will also be assessed using the Harris Hip Score, which has been used for patients with post-traumatic arthritis undergoing conversion to total hip arthroplasty.
All patients will be followed as standard of care for their follow up visits at 6 month and 1 year. As the patient population at Shock Trauma and University of Maryland Medical Center are all treated by the same orthopaedic group, one dedicated investigator will follow their outcomes. To minimize the risk of bias, I, the individual administering the WOMAC or SF-36 will be blinded to the patient's treatment arm. As the patient will be giving consent for their treatment, they cannot be blinded. Also, the surgeons (and the research coordinator) will know which group the patient is in, but the investigator collecting the data will not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Patients will be randomized t wo treatment groups : 1. Open reduction internal fixation (ORIF) 2. Acute primary total hip athroplasty (THA) +ORIF. These are both two standard accepted treatments for this injury. Participants who do not consent to being randomized will be asked if they would consent to participating in an observational arm. In this case, type of surgery would be planned and chosen by clinical decision making from the surgeon and patient. As these procedures are both standard of care, partipants could end up in either group as well. All follow up will be the same.
| Arm | Type | Receives |
|---|---|---|
| RCT - ORIF | Active comparator | Procedure: Open Reduction internal FixationA patient in this study arm consents to randomization and receives RCT - ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation. |
| RCT - (THA) + ORIF | Active comparator | Procedure: Open Reduction Internal Fixation with Total Hip ArthroscopyA patient in this study arm consents to randomization and receives RCT - (THA) + ORIF as his/her treatment assignment. He/she will have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty. |
| OBS - ORIF | No intervention | –A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation. |
| OBS (THA) + ORIF | No intervention | –A patient in this study arm does not consent to randomization, but does agree to be involved in the observational study. He/she decides, with input from his/her surgeon, to have his/her acetabular fracture treated by open reduction internal fixation with primary total hip arthroplasty. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 60 years and older at the time of injury who have sustained an acetabular fracture
- Fluent in the English Language
Key exclusion criteria (5 listed)
- Patients under the Age of 60 years old
- Patients who are medically contraindicated for surgery
- Patients who in the surgeon's view will be unable to comply with posterior hip precautions (to prevent dislocation) after surgery
- In patients with bilateral acetabular fractures, the most severe side will be randomized into the study while the other side will be treated but not included in the study.
- Open Injuries
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 |
|---|---|---|
| Open Reduction internal FixationA surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture. | Procedure or surgery | RCT - ORIF |
| Open Reduction Internal Fixation with Total Hip ArthroscopyA surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture, and replaces the cartilage and bone of the greater trochanter with prosthetic components. | Procedure or surgery | RCT - (THA) + ORIF |
Primary outcome
The primary outcome measure for this study is the proportion of complications in the first 12 months following surgery
Time frame: 1 year
Researchers will assess treatment success using a two-group comparison of proportion of complications between the treatment groups during the first 12 months following treatment. Complications will be identified by radiographic and clinical evaluation during standard follow-up appointments with the treating surgeon. Complications include postoperative infections, non-union, mal-union, development of heterotopic bone, development of osteoarthritis, osteolysis, hardware failure, hip dislocations, surgical revisions, and any other condition related to surgical treatment of the study injury.
2 secondary outcomes
A secondary outcome for this study is to evaluate patient reported outcomes using the WOMAC Questionnaire.
Time frame: 6 months and 12 months
A secondary outcome for this study is to evaluate patient reported outcomes using the SF36 Questionnaire.
Time frame: 6 months and 12 months
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 3 Mar 2022.
- Background: PubMed 14574190Anglen JO, Burd TA, Hendricks KJ, Harrison P. The "Gull Sign": a harbinger of failure for internal fixation of geriatric acetabular fractures. J Orthop Trauma. 2003 Oct;17(9):625-34. doi: 10.1097/00005131-200310000-00005.
- Background: PubMed 19047701Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch EH, Swiontkowski M, Sanders D, Walter SD. Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures. J Bone Joint Surg Am. 2008 Dec;90(12):2567-78. doi: 10.2106/JBJS.G.01694.
- Background: PubMed 19318866Boraiah S, Ragsdale M, Achor T, Zelicof S, Asprinio DE. Open reduction internal fixation and primary total hip arthroplasty of selected acetabular fractures. J Orthop Trauma. 2009 Apr;23(4):243-8. doi: 10.1097/BOT.0b013e3181923fb8.
- Background: PubMed 12377902Buckley R, Tough S, McCormack R, Pate G, Leighton R, Petrie D, Galpin R. Operative compared with nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial. J Bone Joint Surg Am. 2002 Oct;84(10):1733-44. doi: 10.2106/00004623-200210000-00001.
- Background: PubMed 18751805Cornell CN. Management of acetabular fractures in the elderly patient. HSS J. 2005 Sep;1(1):25-30. doi: 10.1007/s11420-005-0101-7.
- Background: PubMed 1624491Helfet DL, Borrelli J Jr, DiPasquale T, Sanders R. Stabilization of acetabular fractures in elderly patients. J Bone Joint Surg Am. 1992 Jun;74(5):753-65.
- Background: PubMed 20418734Herscovici D Jr, Lindvall E, Bolhofner B, Scaduto JM. The combined hip procedure: open reduction internal fixation combined with total hip arthroplasty for the management of acetabular fractures in the elderly. J Orthop Trauma. 2010 May;24(5):291-6. doi: 10.1097/BOT.0b013e3181b1d22a.
- Background: PubMed 9208835Jimenez ML, Tile M, Schenk RS. Total hip replacement after acetabular fracture. Orthop Clin North Am. 1997 Jul;28(3):435-46. doi: 10.1016/s0030-5898(05)70300-x.
- Background: PubMed 18784099Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.
- Background: PubMed 11792772Mears DC, Velyvis JH. Acute total hip arthroplasty for selected displaced acetabular fractures: two to twelve-year results. J Bone Joint Surg Am. 2002 Jan;84(1):1-9. doi: 10.2106/00004623-200201000-00001.
- Background: PubMed 8934477Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.
- Background: PubMed 12110735Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.
- Individual participant dataSharing planned: No
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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.
Theodore Manson, MD principal investigator
Associate Professor of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction internal Fixation and Open Reduction Internal Fixation with Total Hip Arthroscopy in people with Acetabular Fracture, run by University of Maryland, Baltimore 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 2 inclusion and 5 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 3 Mar 2022. 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 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.
What does the primary outcome measure?
The primary outcome measure for this study is the proportion of complications in the first 12 months following surgery (time frame: 1 year). 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 NCT03419182, which also lists 33 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 3 Mar 2022.