Celebrex and HO Study

NCT05648916 | Unknown DMC

• 1 other identifier: 2023-8872
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Heterotopic Ossification

Keywords

heterotopic ossification; celecoxib; arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The association between celecoxib and patients with and without heterotopic ossification (HO) following cementless total hip joint replacements.

  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.

  10 mins

Study Arms (2)

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.

Other: Celecoxib

Interventions

Celecoxib OTHER

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

Also known as: Celebrex

Patients with and without HO after Celecoxib clinical pathway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been referred to our outpatient orthopaedic clinic and undergone cementless total hip joint replacement surgery.

You may qualify if:

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

You may not qualify if:

• Revision surgery
• Infections
• Other implants

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Dr, Adam Hart

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (14)

• 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.

  PMID: 26155968 BACKGROUND

• 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.

  PMID: 31044187 BACKGROUND

• 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.

  PMID: 8014651 BACKGROUND

• 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.

  PMID: 8615097 BACKGROUND

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

  PMID: 1277668 BACKGROUND

• 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.

  PMID: 3995821 BACKGROUND

• 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.

  PMID: 29954195 BACKGROUND

• 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.

  PMID: 24474408 BACKGROUND

• 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.

  PMID: 17322426 BACKGROUND

• 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.

  PMID: 33272062 BACKGROUND

• 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.

  PMID: 5783851 BACKGROUND

• 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.

  PMID: 9880181 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 4217797 BACKGROUND

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adam Hart, MD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Orthopaedic Surgeon, Clinical Researcher

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 13, 2022
• Study Start: August 2, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)