Clinical Trial: Study of Pamidronate for the Prevention of Heterotopic Ossification
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Study Into the Effect of Pamidronate for the Prevention of Heterotopic Ossification in High-risk Patients: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether Bisphosphonates in comparison to radiation therapy are effective in the prophylaxis and treatment of heterotopic ossification in high risk patients.
Detailed Summary:
BACKGROUND: The acquired form of heterotopic ossification (HO) is the most common type of extraskeletal ossification and usually precipitated by a trauma such as total hip arthroplasty [THA] or spinal cord injury. After THA the incidence of HO is as high as 50%, but may reach up to 90% in high risk populations leading to severe functional impairment with ankylotic loss of joint mobility. Nonsteroidal anti-inflammatory drugs (NSAIDs) and external radiation have been used in preventing HO. Specifically, patients with surgical resection of HO at the hip have a high postoperative relapsing rate. Best results were observed after prophylactic radiation treatment with disease recurrence in 33-45% of patients. Data on the effect of bisphosphonates in the prevention of postoperative HO are scarce and mainly limited to the use of the first generation bisphosphonate etidronate. In a retrospective observational study we observed a marked beneficial effect of pamidronate infusions: none of the high risk patients with established HO undergoing surgical removal presented with disease recurrence.
AIM: We therefore aim to prospectively confirm our findings and to evaluate the efficacy of pamidronate for the prevention of recurrent HO after surgical removal of ipsilateral HO. Clinical, biochemical and radiological treatment outcome will be compared to standard clinical practice using preoperative external radiation.
ENDPOINTS: Primary endpoint is the radiological HO recurrence rate. Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers).
METHODS: This prospective, randomized trial will be carried out at the University Hospital in Basel/Buderholz in collaboration with the Orthopedic Clinic of the Swiss Paraplegic Centr
Sponsor: University Hospital, Basel, Switzerland
Current Primary Outcome: Primary endpoint is the radiological Heterotopic Ossification recurrence rate. [ Time Frame: 6 month ]
Original Primary Outcome: Primary endpoint is the radiological Heterotopic Ossification recurrence rate.
Current Secondary Outcome: Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers). [ Time Frame: 6 month ]
Original Secondary Outcome: Secondary endpoints are the clinical, functional and biochemical outcome (as assessed by several clinical and laboratory markers).
Information By: University Hospital, Basel, Switzerland
Dates:
Date Received: December 5, 2005
Date Started: June 2005
Date Completion: June 2010
Last Updated: March 9, 2015
Last Verified: March 2015
