Anterior Cruciate Ligament (ACL) Reconstruction using two different types of Femoral Fixation i.e. Mitec Rigidfix femoral polylactide (PLA) cross pin and the Anthrex Bio Transfix implant
| ISRCTN | ISRCTN80878260 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80878260 |
| Protocol serial number | N0020129460 |
| Sponsor | Department of Health |
| Funder | Barking, Havering and Redbridge Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/02/2017
- 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 Ahmad Ali
Scientific
Scientific
Orthopaedics
Oldchurch Hospital
Romford
RM7 0BE
United Kingdom
| Phone | +44 (0)1708 708 478 |
|---|---|
| amali@rcsed.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 | Anterior Cruciate Ligament (ACL) Reconstruction using two different types of Femoral Fixation i.e. Mitec Rigidfix femoral polylactide (PLA) cross pin and the Anthrex Bio Transfix implant |
| Study objectives | Is there any difference in the outcome of the ACL reconstruction using two types of femoral fixation? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anterior cruciate ligament reconstruction |
| Intervention | Patients with ACL deficiency to be reconstructed using hamstring graft (4 strands) with two types of fixture. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | International Knee Documentation Committee (IKDC) scoring system - tagner scoring system |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 ligament reconstruction patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oldchurch Hospital
Romford
RM7 0BE
United Kingdom
RM7 0BE
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
13/02/2017: No publications found, verifying study status with principal investigator.
