Lumbosacral fusion study
| ISRCTN | ISRCTN98524302 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98524302 |
| Protocol serial number | 940139 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 29/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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 John O'Dowd
Scientific
Scientific
Spinal Disorder Unit
University Hospital NHS Trust
D Floor
West Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 924 9924 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Lumbosacral fusion study |
| Study objectives | The main objective of this study is to measure the difference in outcome when internal fixation techniques are used to augment the spinal fusion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Spinal conditions, lumbosacral joint fixation |
| Intervention | 1. Standard posterior lumbosacral fusion without instrumentation, using corticocancellous autograft from the patient's own iliac crest 2. An identical operation will be performed, with the addition of pedicle screw fixation system |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 200 patients admitted to the Spinal Surgery Unit for L5-S1 and L4-S1 fusion for back pain and one of the following diagnostic groups will be entered into the trial: 1. Discogenic back pain 2. Lumbar spondylolysis 3. Degenerative spondylolisthesis 4. Isthmic spondylolisthesis 5. Segmental instability 6. Degenerative scoliosis 7. Failed decompressive surgery |
| Key exclusion criteria | 1. Patients who have predominantly root symptoms 2. Patients who have had previous fusion or stabilisation surgery 3. Patients who are aged over 60 |
| Date of first enrolment | 01/02/1995 |
| Date of final enrolment | 31/01/1998 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Spinal Disorder Unit
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
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
29/10/2019: No publications found. All search options exhausted.
