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Low recruitment rate
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A prospective, interventional, monocentric, controlled and randomized study will compare a conventional surgical technique to a surgical technique with the assistance of the Acetabular Cup Orientation Guide (ACOG, Materialise) System during total hip replacement (THR).
Background: The Acetabular Cup Orientation Guide(ACOG) System from MATERIALISE NV was developed and is intended to be used as a surgical instrument to assist in the positioning of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative computed tomography (CT) imaging scans.
Use of ACOG is a relative new technique. ACOG, based on CT imaging data, fit directly into the patient's anatomy and enable primary total hip replacement . Data showing extra benefit of this technique compared to conventional THR technique are not widely available.
Aim: To determine the safety of this new surgical technique compared to conventional THR.
Methods: 30 participants will be randomized to 2 groups. One group will be operated for a THR with the conventional technique and the other group will be operated for a THR with the assistance of the ACOG System. CT imaging will be taken pre and post operatively to measure cup orientation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THR with conventional technique | Active Comparator | Use of conventional technique in THR |
|
| THR with ACOG | Experimental | THR with Acetabular Cup Orientation Guides (ACOG) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THR with conventional technique | Procedure | THR with conventional technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acetabular cup positioning | Full leg computed tomography pre-operatively and post-operatively. Cup positioning will be recorded in both groups. | 2 Months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | 1 day | |
| Acetabular cup size | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pieter Dolhain | AZ Monica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica | Antwerp | 2018 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19248055 | Result | Hananouchi T, Saito M, Koyama T, Hagio K, Murase T, Sugano N, Yoshikawa H. Tailor-made surgical guide based on rapid prototyping technique for cup insertion in total hip arthroplasty. Int J Med Robot. 2009 Jun;5(2):164-9. doi: 10.1002/rcs.243. | |
| 19629605 | Result | Hananouchi T, Saito M, Koyama T, Sugano N, Yoshikawa H. Tailor-made Surgical Guide Reduces Incidence of Outliers of Cup Placement. Clin Orthop Relat Res. 2010 Apr;468(4):1088-95. doi: 10.1007/s11999-009-0994-4. Epub 2009 Jul 24. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013912 | Threonine |
| ID | Term |
|---|---|
| D000601 | Amino Acids, Essential |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D021542 | Amino Acids, Neutral |
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| THR with Acetabular Cup Orientation Guides (ACOG) | Procedure | THR with the ACOG System. |
|
|
| D012216 |
| Rheumatic Diseases |