Clinical evaluation comparing minimally invasive and standard skin incisions in cementless total hip arthroplasty using the Bimetric Hip system with the 38mm M2A cup. Clinical evaluation of incision size in total hip replacement
| ISRCTN | ISRCTN17429244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17429244 |
| Protocol serial number | N0360178753 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health (UK) |
| Funder | North Hampshire Hospitals NHS Trust (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 18/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr James Calder
Scientific
Scientific
North Hampshire Hospital NHS Trust
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
| Phone | +44 (0)1256 313156 |
|---|---|
| j.calder@ic.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Clinical evaluation comparing minimally invasive and standard skin incisions in cementless total hip arthroplasty using the Bimetric Hip system with the 38mm M2A cup. Clinical evaluation of incision size in total hip replacement |
| Study objectives | 1. Does a small incision (minimally invasive) provide an improved recovery for patients following total hip arthoplasty? 2. Specifically, is the patient able to mobilise more rapidly, leading to an early discharge from the hospital and does it require less analgesia for control of pain? 3. Are there any complications of performing this procedure that are not observed when using the standard incision? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Arthroplasty |
| Intervention | Patients will be randomised into either the control or test group (small incision) using randomisation envelopes. The envelope will be opened to reveal the study group only when the patient is in the anaesthetic room being prepared for surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Clinical results following minimal incision hip surgery with regards to clinical scores at 6 weeks to 2 years post-operatively. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | 1. <75 years of age 2. Eligible for a cementless primary total hip replacement 3. Pre-op level of pain and function for conventional joint replacement 4. Likelihood of obtaining relief of pain and improved function 5. Full skeletal maturity 6. Ability to follow instructions 7. Good general health for age 8. Willing to return for follow-up evaluations |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/07/2005 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Hampshire Hospital NHS Trust
Basingstoke
RG24 9NA
United Kingdom
RG24 9NA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/05/2017: No publications found in PubMed, verifying study status with principal investigator.
