A comparison between total hip replacement surgery using the Modular Dual Mobility prosthesis and Standard Exeter prosthesis with associated precautions

Modular dual mobility versus standard care (MODUMS) in total hip replacement: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65732978

Enrollment

100

Registered

2020-01-10

Start date

2019-09-01

Completion date

Unknown

Last updated

2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip-joint replacement Surgery Hip-joint replacement

Interventions

A single site randomised controlled trial will be conducted to compare the effectiveness of the Dual Mobility hip replacement to the standard fixed bearing hip replacement. The null hypothesis is that

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients listed for routine primary total hip replacement for osteoarthritis (not trauma) 2. Participants capable of giving informed consent 3. 70 years and over at the time of surgery 4. Suitable for a routine cemented femoral stem and un-cemented acetabular socket

Exclusion criteria

Exclusion criteria: 1. Previous hip replacement on contralateral side - (already familiar with precautions) 2. Patient presentation that would not be eligible for a routine implant 3. Patient is unable to comply with the study protocol 4. Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study or affect the participant’s ability to participate in the study

Design outcomes

Primary

Measure	Time frame
Activities of daily living measured using the OHS questionnaire at baseline and 6 months	—

Secondary

Measure	Time frame
1. Activities of daily living measured using the OHS questionnaire at baseline, 3, and 12 months 2. Pain, stiffness and functional ability measured by the WOMAC from baseline to 3, 6 and 12 months 3. Satisfaction measured using a validated outcome measure at 3, 6 and 12 months 4. Health-related quality of life measured using the Euro Qol five dimensional (EQ5D-3L) at baseline, 3,6 and 12 months 5. Cost of the two interventions from a UK NHS perspective measured using a health service resource use questionnaire will be completed by the patient at the 8 weeks, 6 and 12 month post-surgical research assessment. Data will be collected on the loan equipment issued by the Trust over the period of the study and the costs associated with this. The tariffs associated with surgery, in-patient stay, follow up visits and any treatment for complications will be retrieved from hospital finance records at the end of the follow-up period.	—

Measure

Time frame

1. Activities of daily living measured using the OHS questionnaire at baseline, 3, and 12 months 2. Pain, stiffness and functional ability measured by the WOMAC from baseline to 3, 6 and 12 months 3. Satisfaction measured using a validated outcome measure at 3, 6 and 12 months 4. Health-related quality of life measured using the Euro Qol five dimensional (EQ5D-3L) at baseline, 3,6 and 12 months 5. Cost of the two interventions from a UK NHS perspective measured using a health service resource use questionnaire will be completed by the patient at the 8 weeks, 6 and 12 month post-surgical research assessment. Data will be collected on the loan equipment issued by the Trust over the period of the study and the costs associated with this. The tariffs associated with surgery, in-patient stay, follow up visits and any treatment for complications will be retrieved from hospital finance records at the end of the follow-up period.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026