Celebrex and HO Study

Heterotopic Ossification Clinical Trial

Official title:

The Effect of Celecoxib on Heterotopic Bone Formation Following Cementless Total Hip Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05648916
• Other study ID #: 2023-8872
• Status: Enrolling by invitation
• Start date: August 2, 2022
• Est. completion date: August 2023

Study information

• Verified date: December 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Lastly, investigators will examine the relationship between HO and patient-reported outcome measures (PROMs).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All primary total hip replacements with Cementless Tri-lock BPS (Depuy, Warsaw, IN) with minimum 2 years follow up.

Exclusion Criteria:

• Revision surgery

• Infections

• Other implants

Related Conditions & MeSH terms

• Heterotopic Ossification
• Ossification, Heterotopic

Intervention

Other:
• Celecoxib
Retrospectively comparing patients with and without heterotopic ossification who have been exposed to celecoxib and underwent cementless total hip joint replacement surgery.

Locations

Country	Name	City	State
Canada	Dr, Adam Hart	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Brooker 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. — View Citation

Gebuhr 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. — View Citation

Haffer 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. — View Citation

Harris 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. — View Citation

Joice 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. — View Citation

Meyers 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. — View Citation

Oni 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. — View Citation

Pai 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. — View Citation

Riegler HF, Harris CM. Heterotopic bone formation after total hip arthroplasty. Clin Orthop Relat Res. 1976 Jun;(117):209-16. — View Citation

Ritter 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. — View Citation

Saudan 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. — View Citation

Ware 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. — View Citation

Zahiri 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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 mins
Secondary	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.	10 mins
Secondary	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.	10 mins