Managing Avascular Necrosis Treatments: an Investigational Study (MANTIS)

Not Applicable

Completed

• Conditions: Avascular necrosis of the hip; Musculoskeletal Diseases; Osteonecrosis

• Registration Number: ISRCTN14015902
• Lead Sponsor: niversity of Oxford

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36321501/ (added 03/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-12
• Study Completion: 2020-08-31
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. Early, symptomatic, atraumatic AVN of the hip (Ficat score 1 or 2 using MRI)
2. Aged 18 years or over

Exclusion Criteria

1. Diagnosis not confirmed their diagnosis (Ficat 1 or 2), using MRI, within the last 12 months
2. Renal function (creatinine clearance) of < 30 ml/min (tested within the last 3 months)
3. Adjusted serum calcium levels outside local reference range (tested within the last 3 months)
4. Established osteoarthritis (Kellgren-Lawrence >=2)
5. Previous AVN, femoral head deformity, prior hip surgery or hip fracture in the index hip
6. Current pathology (e.g. osteoporosis) that requires treatment with bisphosphonates
7. Received previous anti-osteoporosis therapy (excluding calcium or vitamin D supplements) that lasted more than 4 weeks for oral treatment or any length of parenteral treatment
8. Contraindications to MRI
9. Contraindications to alendronate therapy (including hypocalcaemia) as listed in the SmPC
10. Planning a pregnancy in the next 12 months or are currently pregnant or breastfeeding
11. Not using appropriate contraception and of child bearing age
12. Have a planned joint preserving surgical procedure of the hip
13. Unable to provide informed consent
14. Unable to commit to follow-up regime
15. Already enrolled in an interventional clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hip function measured using Oxford Hip Score (OHS) at 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Hip function and quality of life (QoL) measured using Oxford Hip Score (OHS), iHOT-33, Hospital Anxiety and Depression Score (HADS) and EQ-5D-5L at baseline, 6, 12, 24 and 36 months<br> 2. Radiological progression measured using x-ray at 12 and 36 months and MRI at 36 months<br> 3. Treatment compliance measured using bespoke compliance questionnaires at 1, 2, 3, 6, 9, and 12 months<br> 4. Cost effectiveness measured using healthcare resource use questionnaires at 6, 12, 24 and 36 months<br>