Heterotopic OssificationNCT05648916
Celebrex and HO Study
An observational study of Heterotopic Ossification, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The primary goal of this observational study is to demonstrate the incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacement surgery over time and secondly, demonstrate the relationship between celecoxib and HO formation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heterotopic Ossification
- What is being tested?
- Celecoxib
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 2 Aug 2022to Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been referred to our outpatient orthopaedic clinic and undergone cementless total hip joint replacement surgery.
Who may be able to join
- All primary total hip replacements with Cementless Tri-lock BPS (Depuy, Warsaw, IN) with minimum 2 years follow up.
Who cannot join
- Revision surgery
- Infections
- Other implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Celecoxib on Heterotopic Bone Formation Following Cementless Total Hip Arthroplasty
The primary goal of this observational study is to demonstrate the incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacement surgery over time and secondly, demonstrate the relationship between celecoxib and HO formation. Lastly, investigators will examine the relationship between HO and patient-reported outcome measures (PROMs).
Read the detailed description
Heterotopic ossification (HO) is characterized by the pathologic formation of mature lamellar bone in muscle and soft tissue. It presents clinically with localized pain, reduced motion, and swelling. The process of HO occurs due to abnormal tissue repair, and most commonly occurs in young adults. Significant predisposing factors include total hip arthroplasty (THA), fractures, spinal cord and traumatic brain injuries, and thermal injuries. The overall incidence of HO is up 42% to 57% after THA, and the incidence of extensive HO post THA is 2% to 7%. Certain patient and surgical-related factors have been associated with an increased risk of HO. Patient aspects include a history of Paget's disease, ankylosing spondylitis, and hypertrophic osteoarthritis; surgical factors include the use of cemented implants and prolonged time of ischemia. Post-operative celecoxib use has been associated with a significant lower incidence of HO compared to controls. Furthermore, among COX-2 selective inhibitors, celecoxib has been associated with the lowest incidence of HO.
This study looks at patients who have been referred to our orthopaedic clinic and undergone cementless total hip joint replacement surgery through a retrospective review of our pre-existing departmental database. All the data from all patients who meet the inclusion criteria will be collected from our database. Specifically, the age, gender, BMI, pre-operative diagnosis, post operative radiotherapy, preoperative patient-reported outcome measures (PROMs), post-operative PROMs, operative characteristics, and complications. Data from the available PROMs database will need to be converted into a manageable format that is suitable for data analysis. This study looks at the Harris Hip Score, the UCLA Activity Score, and SF-12 PROMs that are collected from each patient as standard of care. Descriptive statistics and para/nonparametric statistics will be used to analyze the data through IBM SPSS software platform for statistical analysis. The independent student t-test and multivariable logistic regression analysis will be used to examine outcome measures.
- Conditions
- Heterotopic Ossification
- Being tested
- Celecoxib
- Keywords
- heterotopic ossification, celecoxib, arthroplasty
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibOther
Also called Celebrex
Retrospectively comparing patients with and without heterotopic ossification who have been exposed to celecoxib and underwent cementless total hip joint replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients with and without HO before Celecoxib clinical pathway | Patients with and without heterotopic ossification (HO) before the clinical pathway was changed to include celecoxib following cementless total hip joint replacement surgery between periods 2009-2012. | |
| Patients with and without HO after Celecoxib clinical pathway | Patients with and without heterotopic ossification (HO) after the clinical pathway was changed to include celecoxib following cementless total hip joint replacement surgery between periods 2013-2020. Receives: Other: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacements over time.
The percentage of patients with HO who have undergone cementless total hip joint replacement surgery over time.
Measured: 10 mins
Secondary outcomes (2)
The association between celecoxib and patients with and without heterotopic ossification (HO) following cementless total hip joint replacements.
The probability between the use of celecoxib and patients with and without heterotopic ossification following cementless total hip joint replacement surgery.
Measured: 10 mins
The association between heterotopic ossification (HO) and celecoxib and between HO and patient-reported outcome measures in patients with cementless total hip joint replacements.
The probability between heterotopic ossification (HO) and the use of celecoxib and between HO and patient-reported outcome measures.
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start2 Aug 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Heterotopic OssificationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hart, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Adam Hart, MD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648916
- Sponsor's protocol ID
- 2023-8872
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Y, Zhang F, Chen W, Zhang Q, Liu S, Zhang Y. Incidence and risk factors for heterotopic ossification after total hip arthroplasty: a meta-analysis. Arch Orthop Trauma Surg. 2015 Sep;135(9):1307-14. doi: 10.1007/s00402-015-2277-8. Epub 2015 Jul 9.
PubMed 26155968Meyers C, Lisiecki J, Miller S, Levin A, Fayad L, Ding C, Sono T, McCarthy E, Levi B, James AW. Heterotopic Ossification: A Comprehensive Review. JBMR Plus. 2019 Feb 27;3(4):e10172. doi: 10.1002/jbm4.10172. eCollection 2019 Apr.
PubMed 31044187Pai VS. Heterotopic ossification in total hip arthroplasty. The influence of the approach. J Arthroplasty. 1994 Apr;9(2):199-202. doi: 10.1016/0883-5403(94)90069-8.
PubMed 8014651Gebuhr P, Sletgard J, Dalsgard J, Soelberg M, Keisu K, Hanninen A, Crawford M. Heterotopic ossification after hip arthroplasty: a randomized double-blind multicenter study tenoxicam in 147 hips. Acta Orthop Scand. 1996 Feb;67(1):29-32. doi: 10.3109/17453679608995604.
PubMed 8615097Riegler HF, Harris CM. Heterotopic bone formation after total hip arthroplasty. Clin Orthop Relat Res. 1976 Jun;(117):209-16.
PubMed 1277668Ritter MA, Sieber JM. Prophylactic indomethacin for the prevention of heterotopic bone formation following total hip arthroplasty. Clin Orthop Relat Res. 1985 Jun;(196):217-25.
PubMed 3995821Joice M, Vasileiadis GI, Amanatullah DF. Non-steroidal anti-inflammatory drugs for heterotopic ossification prophylaxis after total hip arthroplasty: a systematic review and meta-analysis. Bone Joint J. 2018 Jul;100-B(7):915-922. doi: 10.1302/0301-620X.100B7.BJJ-2017-1467.R1.
PubMed 29954195Oni JK, Pinero JR, Saltzman BM, Jaffe FF. Effect of a selective COX-2 inhibitor, celecoxib, on heterotopic ossification after total hip arthroplasty: a case-controlled study. Hip Int. 2014 May-Jun;24(3):256-62. doi: 10.5301/hipint.5000109. Epub 2014 Jan 28.
PubMed 24474408Saudan M, Saudan P, Perneger T, Riand N, Keller A, Hoffmeyer P. Celecoxib versus ibuprofen in the prevention of heterotopic ossification following total hip replacement: a prospective randomised trial. J Bone Joint Surg Br. 2007 Feb;89(2):155-9. doi: 10.1302/0301-620X.89B2.17747.
PubMed 17322426Haffer H, Muller M, Ascherl R, Perka C, Winkler T. Diclofenac for prophylaxis of heterotopic ossification after hip arthroplasty: a systematic review. Hip Int. 2022 Mar;32(2):144-151. doi: 10.1177/1120700020978194. Epub 2020 Dec 3.
PubMed 33272062Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
PubMed 5783851Zahiri CA, Schmalzried TP, Szuszczewicz ES, Amstutz HC. Assessing activity in joint replacement patients. J Arthroplasty. 1998 Dec;13(8):890-5. doi: 10.1016/s0883-5403(98)90195-4.
PubMed 9880181Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Brooker AF, Bowerman JW, Robinson RA, Riley LH Jr. Ectopic ossification following total hip replacement. Incidence and a method of classification. J Bone Joint Surg Am. 1973 Dec;55(8):1629-32. No abstract available.
PubMed 4217797
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Celecoxib on Heterotopic Bone Formation Following Cementless Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05648916
- Acronym / sponsor ID
- 2023-8872
- Conditions
- Heterotopic Ossification
- Keywords
- heterotopic ossification, celecoxib, arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 13 Dec 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 primary goal of this observational study is to demonstrate the incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacement surgery over time and secondly, demonstrate the relationship between celecoxib and HO formation. Lastly, investigators will examine the relationship between HO and patient-reported outcome measures (PROMs).
Detailed description
Heterotopic ossification (HO) is characterized by the pathologic formation of mature lamellar bone in muscle and soft tissue. It presents clinically with localized pain, reduced motion, and swelling. The process of HO occurs due to abnormal tissue repair, and most commonly occurs in young adults. Significant predisposing factors include total hip arthroplasty (THA), fractures, spinal cord and traumatic brain injuries, and thermal injuries. The overall incidence of HO is up 42% to 57% after THA, and the incidence of extensive HO post THA is 2% to 7%. Certain patient and surgical-related factors have been associated with an increased risk of HO. Patient aspects include a history of Paget's disease, ankylosing spondylitis, and hypertrophic osteoarthritis; surgical factors include the use of cemented implants and prolonged time of ischemia. Post-operative celecoxib use has been associated with a significant lower incidence of HO compared to controls. Furthermore, among COX-2 selective inhibitors, celecoxib has been associated with the lowest incidence of HO.
This study looks at patients who have been referred to our orthopaedic clinic and undergone cementless total hip joint replacement surgery through a retrospective review of our pre-existing departmental database. All the data from all patients who meet the inclusion criteria will be collected from our database. Specifically, the age, gender, BMI, pre-operative diagnosis, post operative radiotherapy, preoperative patient-reported outcome measures (PROMs), post-operative PROMs, operative characteristics, and complications. Data from the available PROMs database will need to be converted into a manageable format that is suitable for data analysis. This study looks at the Harris Hip Score, the UCLA Activity Score, and SF-12 PROMs that are collected from each patient as standard of care. Descriptive statistics and para/nonparametric statistics will be used to analyze the data through IBM SPSS software platform for statistical analysis. The independent student t-test and multivariable logistic regression analysis will be used to examine outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with and without HO before Celecoxib clinical pathway | – | –Patients with and without heterotopic ossification (HO) before the clinical pathway was changed to include celecoxib following cementless total hip joint replacement surgery between periods 2009-2012. |
| Patients with and without HO after Celecoxib clinical pathway | – | Other: CelecoxibPatients with and without heterotopic ossification (HO) after the clinical pathway was changed to include celecoxib following cementless total hip joint replacement surgery between periods 2013-2020. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been referred to our outpatient orthopaedic clinic and undergone cementless total hip joint replacement surgery.
Key inclusion criteria (1 listed)
- All primary total hip replacements with Cementless Tri-lock BPS (Depuy, Warsaw, IN) with minimum 2 years follow up.
Key exclusion criteria (3 listed)
- Revision surgery
- Infections
- Other implants
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 |
|---|---|---|
| CelecoxibAlso: CelebrexRetrospectively comparing patients with and without heterotopic ossification who have been exposed to celecoxib and underwent cementless total hip joint replacement surgery. | Other | Patients with and without HO after Celecoxib clinical pathway |
Primary outcome
Incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacements over time.
Time frame: 10 mins
The percentage of patients with HO who have undergone cementless total hip joint replacement surgery over time.
2 secondary outcomes
The association between celecoxib and patients with and without heterotopic ossification (HO) following cementless total hip joint replacements.
Time frame: 10 mins
The association between heterotopic ossification (HO) and celecoxib and between HO and patient-reported outcome measures in patients with cementless total hip joint replacements.
Time frame: 10 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 26155968Zhu Y, Zhang F, Chen W, Zhang Q, Liu S, Zhang Y. Incidence and risk factors for heterotopic ossification after total hip arthroplasty: a meta-analysis. Arch Orthop Trauma Surg. 2015 Sep;135(9):1307-14. doi: 10.1007/s00402-015-2277-8. Epub 2015 Jul 9.
- Background: PubMed 31044187Meyers C, Lisiecki J, Miller S, Levin A, Fayad L, Ding C, Sono T, McCarthy E, Levi B, James AW. Heterotopic Ossification: A Comprehensive Review. JBMR Plus. 2019 Feb 27;3(4):e10172. doi: 10.1002/jbm4.10172. eCollection 2019 Apr.
- Background: PubMed 8014651Pai VS. Heterotopic ossification in total hip arthroplasty. The influence of the approach. J Arthroplasty. 1994 Apr;9(2):199-202. doi: 10.1016/0883-5403(94)90069-8.
- Background: PubMed 8615097Gebuhr P, Sletgard J, Dalsgard J, Soelberg M, Keisu K, Hanninen A, Crawford M. Heterotopic ossification after hip arthroplasty: a randomized double-blind multicenter study tenoxicam in 147 hips. Acta Orthop Scand. 1996 Feb;67(1):29-32. doi: 10.3109/17453679608995604.
- Background: PubMed 1277668Riegler HF, Harris CM. Heterotopic bone formation after total hip arthroplasty. Clin Orthop Relat Res. 1976 Jun;(117):209-16.
- Background: PubMed 3995821Ritter MA, Sieber JM. Prophylactic indomethacin for the prevention of heterotopic bone formation following total hip arthroplasty. Clin Orthop Relat Res. 1985 Jun;(196):217-25.
- Background: PubMed 29954195Joice M, Vasileiadis GI, Amanatullah DF. Non-steroidal anti-inflammatory drugs for heterotopic ossification prophylaxis after total hip arthroplasty: a systematic review and meta-analysis. Bone Joint J. 2018 Jul;100-B(7):915-922. doi: 10.1302/0301-620X.100B7.BJJ-2017-1467.R1.
- Background: PubMed 24474408Oni JK, Pinero JR, Saltzman BM, Jaffe FF. Effect of a selective COX-2 inhibitor, celecoxib, on heterotopic ossification after total hip arthroplasty: a case-controlled study. Hip Int. 2014 May-Jun;24(3):256-62. doi: 10.5301/hipint.5000109. Epub 2014 Jan 28.
- Background: PubMed 17322426Saudan M, Saudan P, Perneger T, Riand N, Keller A, Hoffmeyer P. Celecoxib versus ibuprofen in the prevention of heterotopic ossification following total hip replacement: a prospective randomised trial. J Bone Joint Surg Br. 2007 Feb;89(2):155-9. doi: 10.1302/0301-620X.89B2.17747.
- Background: PubMed 33272062Haffer H, Muller M, Ascherl R, Perka C, Winkler T. Diclofenac for prophylaxis of heterotopic ossification after hip arthroplasty: a systematic review. Hip Int. 2022 Mar;32(2):144-151. doi: 10.1177/1120700020978194. Epub 2020 Dec 3.
- Background: PubMed 5783851Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
- Background: PubMed 9880181Zahiri CA, Schmalzried TP, Szuszczewicz ES, Amstutz HC. Assessing activity in joint replacement patients. J Arthroplasty. 1998 Dec;13(8):890-5. doi: 10.1016/s0883-5403(98)90195-4.
- 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.
Adam Hart, MD principal investigator
Research Institute of the McGill University Health Centre
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 Heterotopic Ossification, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 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 15 Dec 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 Canada. 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?
Incidence of heterotopic ossification (HO) in patients with cementless total hip joint replacements over time. (time frame: 10 mins). 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 NCT05648916, which also lists 14 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 15 Dec 2022.