Hip OsteoarthritisNCT05507073
A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
A study testing Manual Total Hip Replacement and Robot-Assisted Total Hip Replacement in people with Hip Osteoarthritis and Post-traumatic Osteoarthritis, run by The Royal Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Post-traumatic Osteoarthritis, Inflammatory Arthritis
- What is being tested?
- Manual Total Hip Replacement and Robot-Assisted Total Hip Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2021to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Male or Female, aged 18 to 85 years at recruitment into trial
- Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, , or congenital or developmental hip disease, avascular necrosis of the hip
- Listed for total hip replacement
- Suitable for Accolade 2 stem and Trident cup prostheses
- Female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial
- In the Investigator's opinion, is able and willing to comply with all trial requirements
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Who cannot join
- Inability to provide informed consent
- Previous surgery to the ipsilateral hip and implantation of metalwork.
- Significant co-morbidities that would make follow up difficult or uncomfortable
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Pregnancy or intention to become pregnant within the trial period.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Orthopaedic Hospital NHS Trust
Birmingham
Gareth Stephens, 01216854120, gareth.stephens@nhs.net
About this study
Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.
Read the detailed description
This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial.
Arm 1: Manual total hip replacement with conventional templating Arm 2: Robotic total hip replacement In the study 25 participants will receive manual THR with conventional templating; the other 25 will receive Robotic THR.
Following recruitment in outpatient clinics, participants will undergo baseline assessments, including imaging and clinical assessment. All participants will then undergo THR surgery, which will likely entail an inpatient hospital stay of 1-2 days. Post-operative rehabilitation will be in line with the normal standard care for all participants. Post-operatively participants will make two visits to clinic at 6 weeks and 12 months (standard of care).
- Conditions
- Hip Osteoarthritis, Post-traumatic Osteoarthritis, Inflammatory Arthritis, Congenital Hip Problems, Avascular Necrosis of Hip
- Being tested
- Manual Total Hip Replacement, Robot-Assisted Total Hip Replacement
- Keywords
- hip replacement, THR, Robotic, Arthroplasty, Hip Surgery, Range of Motion
- Medical subject headings
- Osteoarthritis, Hip, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Total Hip ReplacementProcedure or surgery
Also called Hip Arthroplasty, Hip Replacement, Total Hip Replacement
Implantation of a hip Device to alleviate pain and recover range of movement
Robot-Assisted Total Hip ReplacementProcedure or surgery
Also called Hip replacement, Robotic Hip replacement, Robot Assisted Hip Arthroplasty
Robot assisted Implantation of a hip Device to alleviate pain and recover range of movement
| Study group | Role | What they receive |
|---|---|---|
| Manual Total Hip Replacement | Active comparator | Manual Total Hip Replacement Receives: Procedure: Manual Total Hip Replacement |
| Robot-Assisted Total Hip Replacement | Experimental | Robot-Assisted Total Hip Replacement Receives: Procedure: Robot-Assisted Total Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR
Measured: 6 weeks post-intervention
Secondary outcomes (6)
Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
Measured: 12 months
Using the Oxford Hip score to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
Measured: 12 months
Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures
To determine whether the Robotic THR improves patient reported outcome measures
Measured: 12 months
Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.
To determine whether Robotic Surgery reduces leg length Discrepancy compared to manual THR
Measured: 12 months
Measure the duration of surgery and compare the duration of robotic THR to manual THR
To determine whether the Robotic THR increases operation duration compared to Manual surgery
Measured: During Surgery
Measure and compare the length of stay between Robotic and Manual THR surgeries
To determine if length of hospital stay is reduced after robotic THR .
Measured: During length of stay in hospital average 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start6 Apr 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial. Any participant that withdraws from the study will be replaced.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507073
- Sponsor's protocol ID
- ROH20ORTH16
- Status last verified
- Aug 2023
- First submitted
- 27 Jun 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Impingement Free Range of Motion With CT Scan After Manual and Robotic Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05507073
- Acronym / sponsor ID
- ROH20ORTH16
- Conditions
- Hip Osteoarthritis, Post-traumatic Osteoarthritis, Inflammatory Arthritis, Congenital Hip Problems, Avascular Necrosis of Hip
- Keywords
- hip replacement, THR, Robotic, Arthroplasty, Hip Surgery, Range of Motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Royal Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-blinded randomised controlled trial comparing impingement with CT scan for manual and robotic total hip replacement. A pilot study of 50 participants.
Detailed description
This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial.
Arm 1: Manual total hip replacement with conventional templating Arm 2: Robotic total hip replacement In the study 25 participants will receive manual THR with conventional templating; the other 25 will receive Robotic THR.
Following recruitment in outpatient clinics, participants will undergo baseline assessments, including imaging and clinical assessment. All participants will then undergo THR surgery, which will likely entail an inpatient hospital stay of 1-2 days. Post-operative rehabilitation will be in line with the normal standard care for all participants. Post-operatively participants will make two visits to clinic at 6 weeks and 12 months (standard of care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a two-arm, single blind (assessor blind), randomised controlled group study. It will take place in the NHS hospital setting. Stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial. Any participant that withdraws from the study will be replaced.
| Arm | Type | Receives |
|---|---|---|
| Manual Total Hip Replacement | Active comparator | Procedure: Manual Total Hip ReplacementManual Total Hip Replacement |
| Robot-Assisted Total Hip Replacement | Experimental | Procedure: Robot-Assisted Total Hip ReplacementRobot-Assisted Total Hip Replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or Female, aged 18 to 85 years at recruitment into trial
- Diagnosed with hip OA, post-traumatic OA, inflammatory arthropathy, , or congenital or developmental hip disease, avascular necrosis of the hip
- Listed for total hip replacement
- Suitable for Accolade 2 stem and Trident cup prostheses
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Previous surgery to the ipsilateral hip and implantation of metalwork.
- Significant co-morbidities that would make follow up difficult or uncomfortable
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Pregnancy or intention to become pregnant within the trial period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Total Hip ReplacementAlso: Hip Arthroplasty, Hip Replacement, Total Hip ReplacementImplantation of a hip Device to alleviate pain and recover range of movement | Procedure or surgery | Manual Total Hip Replacement |
| Robot-Assisted Total Hip ReplacementAlso: Hip replacement, Robotic Hip replacement, Robot Assisted Hip ArthroplastyRobot assisted Implantation of a hip Device to alleviate pain and recover range of movement | Procedure or surgery | Robot-Assisted Total Hip Replacement |
Primary outcome
Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR
Time frame: 6 weeks post-intervention
To compare efficacy of Robotic THR in reducing post-operative impingement with Standard Manual THR
6 secondary outcomes
Using the Forgotten Joint Score (FJS-12) to determine improvement in Patient reported outcome measures
Time frame: 12 months
Using the Oxford Hip score to determine improvement in Patient reported outcome measures
Time frame: 12 months
Using the EuroQol 5-D (EQ5-D) to determine improvement in Patient reported outcome measures
Time frame: 12 months
Measure leg length following surgery to determine whether robotic THR or manual THR is more effective at reducing leg length discrepancy.
Time frame: 12 months
Measure the duration of surgery and compare the duration of robotic THR to manual THR
Time frame: During Surgery
Measure and compare the length of stay between Robotic and Manual THR surgeries
Time frame: During length of stay in hospital average 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Total Hip Replacement and Robot-Assisted Total Hip Replacement in people with Hip Osteoarthritis and Post-traumatic Osteoarthritis, run by The Royal Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward T Davis, MD (01216854000 ext. 55306, edward.davis@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impingement analysis by a CT guided software in all participants to enable a comparison of post-operative impingement between robotic THR and manual THR (time frame: 6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.